Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01150045

Collaborator

National Cancer Institute (NCI) (NIH)

2,527

Enrollment

842

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief Summary

PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: celecoxib Drug: 5-fluorouracil Other: placebo Drug: oxaliplatin Drug: leucovorin	Phase 3

Detailed Description

OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more information. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. The primary and secondary objectives for the research study are described below.

Primary objective:

To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib 400 mg daily.

Secondary objectives:

To contribute to an international prospective pooled analysis that will compare disease-free survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
To compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.
To contribute to an international prospective pooled analysis that will compare overall survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage III colon cancer.
To assess differences in cardiovascular-specific events with celecoxib versus placebo in a population of stage III colon cancer survivors.
To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, for patients treated with 6 treatments of FOLFOX compared to those treated with 12 treatments of FOLFOX.

After completion of study therapy, patients are followed up every 6 months for up to 6 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

2527 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A - FOLFOX and placebo (12 treatments) Patients receive FOLFOX every 2 weeks plus placebo every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.	Drug: 5-fluorouracil Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours. Other: placebo Patients receive placebo administered by mouth, once daily. Drug: oxaliplatin Patients receive 85 mg/m^2 intravenous over two hours. Drug: leucovorin Patients receive 400 mg/m^2 intravenous over two hours.
Experimental: Arm B - FOLFOX and celecoxib (12 treatments) Patients receive FOLFOX every 2 weeks plus celecoxib every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.	Drug: celecoxib Patients receive celecoxib 400 mg administered by mouth, once daily. Drug: 5-fluorouracil Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours. Drug: oxaliplatin Patients receive 85 mg/m^2 intravenous over two hours. Drug: leucovorin Patients receive 400 mg/m^2 intravenous over two hours.
Active Comparator: Arm C - FOLFOX and placebo (6 treatments) Patients receive FOLFOX every 2 weeks plus placebo every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.	Drug: 5-fluorouracil Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours. Other: placebo Patients receive placebo administered by mouth, once daily. Drug: oxaliplatin Patients receive 85 mg/m^2 intravenous over two hours. Drug: leucovorin Patients receive 400 mg/m^2 intravenous over two hours.
Experimental: Arm D - FOLFOX and celecoxib (6 treatments) Patients receive FOLFOX every 2 weeks plus celecoxib every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.	Drug: celecoxib Patients receive celecoxib 400 mg administered by mouth, once daily. Drug: 5-fluorouracil Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours. Drug: oxaliplatin Patients receive 85 mg/m^2 intravenous over two hours. Drug: leucovorin Patients receive 400 mg/m^2 intravenous over two hours.

Outcome Measures

Primary Outcome Measures

Disease-free Survival [At 3 years of follow-up]
Disease-Free Survival (DFS) is defined as the time of randomization until documented progression or death from any cause. The endpoint of this trial is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive and disease free after 3 years are reported here. A log-rank test stratified with the stratification factors was used to compare disease-free survival (celecoxib vs placebo)

Secondary Outcome Measures

Overall Survival [up to 3 years from registration]
Overall Survival (DFS) is defined as the time of randomization until documented death from any cause. The endpoint is to compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 5 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive after 3 years are reported here.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Requirements for tumor parameters
Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection (i.e., patients with rectal cancer are not eligible). Surgeon confirmation that the entire tumor was above the peritoneal reflection is only required in cases where it is important to establish if the tumor is a rectal or colon primary.
Tumors must have been completely resected. In patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon. Near or positive radial margin are not exclusions as long as en bloc resection was performed. Positive proximal margin or distal margin is an exclusion.
Node positive disease (N1 or N2) as designated in AJCC version 7. Either at least one pathologically confirmed positive lymph node or N1C (defined as tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases). Patients with resected stage IV disease are not eligible.
No evidence of residual involved lymph node disease or metastatic disease at the time of registration.
Patients with synchronous colon cancers are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor. However, patients with synchronous colon and rectal primary tumors are not eligible.
NSAID use

Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average. Low-dose aspirin not exceeding 100 mg/day is permitted. Patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no was out period is required.

Patient history
No previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or any other cancer for which the patient has been disease-free for at least 5 years.
No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration.
No known allergy to platinum compounds.
No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs.
No history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Patients with ulceration, bleeding or perforation in the lower bowel are not excluded.
No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2.
No cardiac risk factors including:

Uncontrolled high blood pressure (systolic blood pressure > 150).
Unstable angina.
History of documented myocardial infarction or cerebrovascular accident.
New York Heart Association class III or IV heart failure.

Pregancy/nursing status

Non-pregnant and not nursing. Men and women of childbearing potential must agree to employ adequate contraception for the duration of chemotherapy and for as many as 8 weeks after the completion of chemotherapy due to the unknown teratogenic effects of FOLFOX on the developing fetus.

Age and performance status
ECOG performance status 0, 1 or 2.
Age at least 18 years.
Required initial laboratory values
Granulocytes ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total Bilirubin ≤ 1.5 times ULN in the absence of Gilbert's disease
Direct bilirubin ≤ 1.5 x upper limit of normal for patients with Gilbert's syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama	United States	36604
2	Alaska Breast Care and Surgery LLC	Anchorage	Alaska	United States	99508
3	Alaska Women's Cancer Care	Anchorage	Alaska	United States	99508
4	Anchorage Oncology Centre	Anchorage	Alaska	United States	99508
5	Katmai Oncology Group	Anchorage	Alaska	United States	99508
6	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
7	Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
8	Fowler Family Center for Cancer Care	Jonesboro	Arkansas	United States	72401
9	Sutter Cancer Centers Radiation Oncology Services-Auburn	Auburn	California	United States	95603
10	Alta Bates Summit Medical Center-Herrick Campus	Berkeley	California	United States	94704
11	Providence Saint Joseph Medical Center-Disney Family Cancer Center	Burbank	California	United States	91505
12	Mills-Peninsula Hospitals	Burlingame	California	United States	94010
13	Sutter Cancer Centers Radiation Oncology Services-Cameron Park	Cameron Park	California	United States	95682
14	John Muir Medical Center-Concord	Concord	California	United States	95420
15	Sutter Davis Hospital	Davis	California	United States	95616
16	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
17	Epic Care-Dublin	Dublin	California	United States	94568
18	Bay Area Breast Surgeons Inc	Emeryville	California	United States	94608
19	Epic Care Partners in Cancer Care	Emeryville	California	United States	94608
20	Comprehensive Cancer Care and Research Institute of Colorado LLC	Englewood	California	United States	80113
21	University Oncology Associates	Fresno	California	United States	93701
22	California Cancer Center - North Fresno	Fresno	California	United States	93720
23	Marin Cancer Care Inc	Greenbrae	California	United States	94904
24	Marin General Hospital	Greenbrae	California	United States	94904
25	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027
26	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033-0804
27	Los Angeles County-USC Medical Center	Los Angeles	California	United States	90033
28	Contra Costa Regional Medical Center	Martinez	California	United States	94553
29	Memorial Medical Center	Modesto	California	United States	95355
30	Palo Alto Medical Foundation-Camino Division	Mountain View	California	United States	94040
31	Palo Alto Medical Foundation-Gynecologic Oncology	Mountain View	California	United States	94040
32	Sutter Cancer Research Consortium	Novato	California	United States	94945
33	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
34	Bay Area Tumor Institute	Oakland	California	United States	94609
35	Hematology and Oncology Associates-Oakland	Oakland	California	United States	94609
36	Saint Joseph Hospital - Orange	Orange	California	United States	92868
37	UC Irvine Health-Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
38	Desert Regional Medical Center	Palm Springs	California	United States	92262
39	Stanford Cancer Institute	Palo Alto	California	United States	94304
40	Palchak David MD	Pismo Beach	California	United States	93449
41	Valley Medical Oncology Consultants	Pleasanton	California	United States	94588
42	Kaiser Permanente-Redwood City	Redwood City	California	United States	94063
43	Kaiser Permanente-Richmond	Richmond	California	United States	94801
44	Kaiser Permanente-Riverside	Riverside	California	United States	92505
45	Kaiser Permanente-Roseville	Roseville	California	United States	95661
46	Sutter Cancer Centers Radiation Oncology Services-Roseville	Roseville	California	United States	95661
47	Sutter Roseville Medical Center	Roseville	California	United States	95661
48	Sutter General Hospital	Sacramento	California	United States	95816
49	University of California Davis Comprehensive Cancer Center	Sacramento	California	United States	95817
50	Saint Helena Hospital	Saint Helena	California	United States	95474
51	Salinas Valley Memorial Hospital	Salinas	California	United States	93901
52	Salinas Valley Memorial	Salinas	California	United States	93901
53	Kaiser Permanente-San Diego Zion	San Diego	California	United States	92120
54	Naval Medical Center-San Diego	San Diego	California	United States	92134
55	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
56	UCSF Medical Center-Mount Zion	San Francisco	California	United States	94115
57	California Pacific Medical Center-Pacific Campus	San Francisco	California	United States	94118
58	Veterans Affairs Medical Center-San Francisco	San Francisco	California	United States	94121
59	UCSF Medical Center-Mission Bay	San Francisco	California	United States	94158
60	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
61	Santa Clara Valley Medical Center	San Jose	California	United States	95128
62	Kaiser Permanente San Leandro	San Leandro	California	United States	94577
63	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
64	Kaiser Permanente Medical Center-Santa Clara	Santa Clara	California	United States	95051
65	Palo Alto Medical Foundation-Santa Cruz	Santa Cruz	California	United States	95065
66	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
67	Sutter Pacific Medical Foundation	Santa Rosa	California	United States	95403
68	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
69	Kaiser Permanente-Stockton	Stockton	California	United States	95210
70	Palo Alto Medical Foundation-Sunnyvale	Sunnyvale	California	United States	94806
71	Sutter Cancer Centers Radiation Oncology Services-Vacaville	Vacaville	California	United States	95687
72	Kaiser Permanente Medical Center-Vacaville	Vacaville	California	United States	95688
73	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
74	Sutter Solano Medical Center/Cancer Center	Vallejo	California	United States	94589
75	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
76	John Muir Medical Center-Walnut Creek	Walnut Creek	California	United States	94598
77	Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado	United States	80012
78	The Medical Center of Aurora	Aurora	Colorado	United States	80012
79	University of Colorado Cancer Center-Anschutz Cancer Pavilion	Aurora	Colorado	United States	80045
80	Boulder Community Hospital	Boulder	Colorado	United States	80301
81	Rocky Mountain Cancer Centers-Boulder	Boulder	Colorado	United States	80304
82	Penrose-Saint Francis Healthcare	Colorado Springs	Colorado	United States	80907
83	Rocky Mountain Cancer Centers-Penrose	Colorado Springs	Colorado	United States	80907
84	Memorial Hospital Colorado Springs	Colorado Springs	Colorado	United States	80909
85	Porter Adventist Hospital	Denver	Colorado	United States	80210
86	Exempla Saint Joseph Hospital	Denver	Colorado	United States	80218
87	Presbyterian-Saint Lukes Medical Center-Health One	Denver	Colorado	United States	80218
88	Rocky Mountain Cancer Centers-Midtown	Denver	Colorado	United States	80218
89	Rocky Mountain Cancer Centers-Rose	Denver	Colorado	United States	80220
90	Rose Medical Center	Denver	Colorado	United States	80220
91	Colorado Cancer Research Program NCORP	Denver	Colorado	United States	80222
92	Colorado Blood Cancer Institute	Denver	Colorado	United States	80907
93	Mercy Medical Center	Durango	Colorado	United States	81301
94	Southwest Oncology PC	Durango	Colorado	United States	81301
95	Swedish Medical Center	Englewood	Colorado	United States	80113
96	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
97	Mountain Blue Cancer Care Center	Golden	Colorado	United States	80401
98	North Colorado Medical Center	Greeley	Colorado	United States	80631
99	Rocky Mountain Cancer Centers-Greenwood Village	Greenwood Village	Colorado	United States	80111
100	Rocky Mountain Cancer Centers-Lakewood	Lakewood	Colorado	United States	80228
101	Saint Anthony Hospital	Lakewood	Colorado	United States	80228
102	Rocky Mountain Cancer Centers-Littleton	Littleton	Colorado	United States	80120
103	Littleton Adventist Hospital	Littleton	Colorado	United States	80122
104	Rocky Mountain Cancer Centers-Sky Ridge	Lone Tree	Colorado	United States	80124
105	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
106	Longmont United Hospital	Longmont	Colorado	United States	80501
107	Rocky Mountain Cancer Centers-Longmont	Longmont	Colorado	United States	80501
108	McKee Medical Center	Loveland	Colorado	United States	80539
109	Parker Adventist Hospital	Parker	Colorado	United States	80138
110	Rocky Mountain Cancer Centers-Parker	Parker	Colorado	United States	80138
111	Rocky Mountain Cancer Centers - Pueblo	Pueblo	Colorado	United States	81008
112	Rocky Mountain Cancer Centers-Thornton	Thornton	Colorado	United States	80260
113	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
114	Hartford Hospital	Hartford	Connecticut	United States	06102
115	Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
116	Midstate Medical Center	Meriden	Connecticut	United States	06451
117	The Hospital of Central Connecticut	New Britain	Connecticut	United States	06050
118	Norwalk Hospital	Norwalk	Connecticut	United States	06856
119	Beebe Medical Center	Lewes	Delaware	United States	19958
120	Christiana Gynecologic Oncology LLC	Newark	Delaware	United States	19713
121	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware	United States	19713
122	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
123	Medical Oncology Hematology Consultants PA	Newark	Delaware	United States	19713
124	Regional Hematology and Oncology PA	Newark	Delaware	United States	19713
125	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
126	Beebe Health Campus	Rehoboth Beach	Delaware	United States	19971
127	Nanticoke Memorial Hospital	Sanford	Delaware	United States	19973
128	Christiana Care Health System-Wilmington Hospital	Wilmington	Delaware	United States	19801
129	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
130	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
131	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
132	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia	United States	20422
133	University of Florida-Gainesville	Gainesville	Florida	United States	32610-0277
134	Memorial Regional Hospital-Joe DiMaggio Children's Hospital	Hollywood	Florida	United States	33021
135	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980
136	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
137	Memorial Hospital West	Pembroke Pines	Florida	United States	33028
138	Robert and Carol Weissman Cancer Center at Martin Health	Stuart	Florida	United States	34994
139	Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31701
140	Emory University/Winship Cancer Institute	Atlanta	Georgia	United States	30322
141	Atlanta VA Medical Center	Decatur	Georgia	United States	30033
142	Dekalb Medical Center	Decatur	Georgia	United States	30033
143	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
144	Medical Center of Central Georgia	Macon	Georgia	United States	31208
145	Low Country Cancer Care Associates PC	Savannah	Georgia	United States	31405
146	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
147	Oncare Hawaii Inc - POB II	Honolulu	Hawaii	United States	96813
148	Queen's Medical Center	Honolulu	Hawaii	United States	96813
149	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
150	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
151	Oncare Hawaii Inc-Kuakini	Honolulu	Hawaii	United States	96817
152	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
153	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii	United States	96819
154	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
155	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
156	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
157	Saint Luke's Mountain States Tumor Institute	Boise	Idaho	United States	83712
158	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho	United States	83619
159	Saint Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
160	Saint Luke's Mountain States Tumor Institute - Meridian	Meridian	Idaho	United States	83642
161	Saint Luke's Mountain States Tumor Institute - Nampa	Nampa	Idaho	United States	83686
162	Saint Luke's Mountain States Tumor Institute-Twin Falls	Twin Falls	Idaho	United States	83301
163	Rush Copley Medical Center	Aurora	Illinois	United States	60504-4206
164	Illinois CancerCare - Bloomington	Bloomington	Illinois	United States	61701
165	Saint Joseph Medical Center	Bloomington	Illinois	United States	61701
166	Illinois CancerCare - Canton	Canton	Illinois	United States	61520
167	Memorial Hospital of Carbondale	Carbondale	Illinois	United States	62902
168	Illinois CancerCare - Carthage	Carthage	Illinois	United States	62321
169	Centralia Oncology Clinic	Centralia	Illinois	United States	62801
170	Northwestern University	Chicago	Illinois	United States	60611
171	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois	United States	60612-3785
172	University of Illinois	Chicago	Illinois	United States	60612
173	Weiss Memorial Hospital	Chicago	Illinois	United States	60640
174	Advocate Illinois Masonic Medical Center	Chicago	Illinois	United States	60657
175	Presence Saint Joseph Hospital-Chicago	Chicago	Illinois	United States	60657
176	Carle on Vermilion	Danville	Illinois	United States	61832
177	Cancer Care Specialists of Central Illinois	Decatur	Illinois	United States	62526
178	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
179	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
180	Crossroads Cancer Center	Effingham	Illinois	United States	62401
181	Advocate Sherman Hospital	Elgin	Illinois	United States	60123
182	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
183	Illinois CancerCare - Eureka	Eureka	Illinois	United States	61530
184	Saint Francis Hospital	Evanston	Illinois	United States	60202
185	Illinois CancerCare - Galesburg	Galesburg	Illinois	United States	61401
186	Western Illinois Cancer Treatment Center	Galesburg	Illinois	United States	61401
187	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
188	Hematology Oncology Associates -Highland Park	Highland Park	Illinois	United States	60035
189	Presence Saint Mary's Hospital	Kankakee	Illinois	United States	60901
190	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois	United States	61443
191	NorthShore Hematology Oncology-Libertyville	Libertyville	Illinois	United States	60048
192	Illinois CancerCare - Macomb	Macomb	Illinois	United States	61455
193	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
194	Garneau, Stewart C MD (UIA Investigator)	Moline	Illinois	United States	61265
195	Spector, David MD (UIA Investigator)	Moline	Illinois	United States	61265
196	Trinity Medical Center	Moline	Illinois	United States	61265
197	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
198	Edward Hospital Cancer Center	Naperville	Illinois	United States	60540
199	Hematology Oncology Consultants Ltd.	Naperville	Illinois	United States	60540
200	Illinois Cancer Specialists-Niles	Niles	Illinois	United States	60714
201	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453-2699
202	Radiation Oncology of Northern Illinois	Ottawa	Illinois	United States	61350
203	Pekin Cancer Treatment Center	Pekin	Illinois	United States	61554
204	Illinois CancerCare - Pekin	Pekin	Illinois	United States	61603
205	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61603
206	OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC	Peoria	Illinois	United States	61615
207	Illinois CancerCare - Peru	Peru	Illinois	United States	61354
208	Valley Radiation Oncology	Peru	Illinois	United States	61354
209	Illinois CancerCare - Princeton	Princeton	Illinois	United States	61356
210	Quincy Medical Group - Clinic	Quincy	Illinois	United States	62301
211	Swedish American Hospital	Rockford	Illinois	United States	61104
212	OSF Saint Anthony Medical Center	Rockford	Illinois	United States	61108
213	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
214	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62702
215	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
216	Springfield Clinic	Springfield	Illinois	United States	62703
217	Memorial Medical Center	Springfield	Illinois	United States	62781-0001
218	Cancer Care Specialists of Illinois-Swansea	Swansea	Illinois	United States	62226
219	Carle Cancer Center	Urbana	Illinois	United States	61801
220	The Carle Foundation Hospital	Urbana	Illinois	United States	61801
221	Cadence Cancer Center in Warrenville	Warrenville	Illinois	United States	60555
222	Michiana Hematology Oncology PC-Crown Point	Crown Point	Indiana	United States	46307
223	Michiana Hematology Oncology PC-Elkhart	Elkhart	Indiana	United States	46514
224	IU Health Central Indiana Cancer Centers-Fishers	Fishers	Indiana	United States	46037
225	Indiana University - Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
226	IU Health Methodist Hospital	Indianapolis	Indiana	United States	46202
227	Sidney and Lois Eskenazi Hospital	Indianapolis	Indiana	United States	46202
228	IU Health Central Indiana Cancer Centers-East	Indianapolis	Indiana	United States	46219
229	IU Health Arnett Cancer Care	Lafayette	Indiana	United States	47904
230	Franciscan Saint Anthony Health-Michigan City	Michigan City	Indiana	United States	46360
231	Memorial Regional Cancer Center Day Road	Mishawaka	Indiana	United States	46544
232	Michiana Hematology Oncology PC-Mishawaka	Mishawaka	Indiana	United States	46545
233	Saint Joseph Regional Medical Center-Mishawaka	Mishawaka	Indiana	United States	46545
234	Michiana Hematology Oncology PC-Plymouth	Plymouth	Indiana	United States	46563
235	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
236	Michiana Hematology Oncology PC-South Bend	South Bend	Indiana	United States	46601
237	Northern Indiana Cancer Research Consrtium	South Bend	Indiana	United States	46628
238	Michiana Hematology Oncology PC-Westville	Westville	Indiana	United States	46391
239	Mary Greeley Medical Center	Ames	Iowa	United States	50010
240	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa	United States	50010
241	Constantinou, Costas L MD (UIA Investigator)	Bettendorf	Iowa	United States	52722
242	Hematology Oncology Associates - Quad Cities	Bettendorf	Iowa	United States	52722
243	McFarland Clinic PC-Boone	Boone	Iowa	United States	50036
244	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
245	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
246	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa	United States	52403
247	Medical Oncology and Hematology Associates - West Des Moines	Clive	Iowa	United States	50325
248	Mercy Cancer Center-West Lakes	Clive	Iowa	United States	50325
249	Alegent Health Mercy Hospital	Council Bluffs	Iowa	United States	51503
250	Genesis Medical Center - East Campus	Davenport	Iowa	United States	52803
251	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
252	Medical Oncology and Hematology Associates - Des Moines	Des Moines	Iowa	United States	50309
253	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
254	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
255	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
256	JCHC McCreery Cancer Center	Fairfield	Iowa	United States	52556
257	McFarland Clinic PC-Trinity Cancer Center	Fort Dodge	Iowa	United States	50501
258	McFarland Clinic PC-Jefferson	Jefferson	Iowa	United States	50129
259	McFarland Clinic PC-Marshalltown	Marshalltown	Iowa	United States	50158
260	Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
261	Ottumwa Regional Health Center	Ottumwa	Iowa	United States	52501
262	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
263	Mercy Medical Center-West Lakes	West Des Moines	Iowa	United States	50266
264	Methodist West Hospital	West Des Moines	Iowa	United States	50266
265	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
266	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
267	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
268	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
269	Hays Medical Center	Hays	Kansas	United States	67601
270	Cancer Center of Kansas - Independence	Independence	Kansas	United States	67301
271	Kansas City Cancer Centers - West	Kansas City	Kansas	United States	66112
272	Cancer Center of Kansas - Kingman	Kingman	Kansas	United States	67068
273	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
274	Cancer Center of Kansas - Liberal	Liberal	Kansas	United States	67901
275	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
276	Menorah Medical Center	Overland Park	Kansas	United States	66209
277	Kansas City Cancer Centers - Southwest	Overland Park	Kansas	United States	66210
278	Saint Luke's South Hospital	Overland Park	Kansas	United States	66213
279	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
280	Kansas City NCI Community Oncology Research Program	Prairie Village	Kansas	United States	66208
281	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
282	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
283	Stormont-Vail Regional Health Center	Topeka	Kansas	United States	66604
284	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
285	Associates In Womens Health	Wichita	Kansas	United States	67208
286	Cancer Center of Kansas - Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
287	Cancer Center of Kansas - Main Office	Wichita	Kansas	United States	67214
288	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
289	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
290	Flaget Memorial Hospital	Bardstown	Kentucky	United States	40004
291	Commonwealth Cancer Center-Corbin	Corbin	Kentucky	United States	40701
292	Baptist Health Corbin	Corbin	Kentucky	United States	40704
293	Oncology Hematology Care Inc-Crestview	Crestview Hills	Kentucky	United States	41017
294	Hardin Memorial Hospital	Elizabethtown	Kentucky	United States	42701
295	Baptist Health Lexington	Lexington	Kentucky	United States	40503
296	Saint Joseph Radiation Oncology Resource Center	Lexington	Kentucky	United States	40504
297	Saint Joseph Hospital East	Lexington	Kentucky	United States	40509
298	Jewish Hospital	Louisville	Kentucky	United States	40202
299	The James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky	United States	40202
300	Baptist Health Louisville	Louisville	Kentucky	United States	40207
301	Saints Mary and Elizabeth Hospital	Louisville	Kentucky	United States	40215
302	Owensboro Health Mitchell Memorial Cancer Center	Owensboro	Kentucky	United States	42303
303	LSU Health Baton Rouge-North Clinic	Baton Rouge	Louisiana	United States	70805
304	Louisiana Hematology Oncology Associates LLC	Baton Rouge	Louisiana	United States	70809
305	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
306	Ochsner Health Center - Covington	Covington	Louisiana	United States	70433
307	East Jefferson General Hospital	Metairie	Louisiana	United States	70006
308	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
309	Interim LSU Public Hospital	New Orleans	Louisiana	United States	70112
310	Louisiana State University Health Science Center	New Orleans	Louisiana	United States	70112
311	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
312	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
313	Harold Alfond Center for Cancer Care	Augusta	Maine	United States	04330
314	Eastern Maine Medical Center	Bangor	Maine	United States	04401
315	Eastern Maine Medical Center Cancer Care	Brewer	Maine	United States	04412
316	Penobscot Bay Medical Center	Rockport	Maine	United States	04856
317	York Hospital	York	Maine	United States	03909
318	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21133
319	Saint Agnes Hospital	Baltimore	Maryland	United States	21229
320	MedStar Franklin Square Medical Center/Weinberg Cancer Institute	Baltimore	Maryland	United States	21237
321	Western Maryland Regional Medical Center	Cumberland	Maryland	United States	21502
322	Frederick Memorial Hospital	Frederick	Maryland	United States	21701
323	Kaiser Permanente - Gaithersburg Medical Center	Gaithersburg	Maryland	United States	20879
324	Meritus Medical Center	Hagerstown	Maryland	United States	21742
325	Holy Cross Hospital	Silver Spring	Maryland	United States	20910
326	Beverly Hospital	Beverly	Massachusetts	United States	01915
327	Tufts Medical Center	Boston	Massachusetts	United States	02111
328	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
329	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
330	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
331	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805
332	MetroWest Medical Center-Framingham Union Hospital	Framingham	Massachusetts	United States	01702
333	Addison Gilbert Hospital	Gloucester	Massachusetts	United States	01930
334	Lowell General Hospital	Lowell	Massachusetts	United States	01854
335	Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center	Milford	Massachusetts	United States	01757
336	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
337	Berkshire Hematology Oncology, PC	Pittsfield	Massachusetts	United States	01201
338	Dana-Farber/Brigham and Women's Cancer Center at South Shore	South Weymouth	Massachusetts	United States	02190
339	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
340	Toledo Clinic Cancer Centers - Adrian	Adrian	Michigan	United States	49221
341	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
342	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0912
343	Bronson Battle Creek	Battle Creek	Michigan	United States	49017
344	Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48124
345	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
346	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
347	Green Bay Oncology-Escanaba	Escanaba	Michigan	United States	49431
348	Botsford Hospital	Farmington	Michigan	United States	48336
349	Hurley Medical Center	Flint	Michigan	United States	48503
350	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
351	Green Bay Oncology-Iron Mountain	Iron Mountain	Michigan	United States	49801
352	Allegiance Health	Jackson	Michigan	United States	49201
353	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
354	Sparrow Hospital	Lansing	Michigan	United States	48912
355	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
356	Toledo Clinic Cancer Centers-Monroe	Monroe	Michigan	United States	48162
357	Lakeland Community Hospital	Niles	Michigan	United States	49120
358	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
359	Saint Joseph Mercy Port Huron	Port Huron	Michigan	United States	48060
360	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
361	Michigan Cancer Specialists	Roseville	Michigan	United States	48066
362	Oakland Colon and Rectal Association	Royal Oak	Michigan	United States	48067
363	Cancer Care Associates PC	Royal Oak	Michigan	United States	48073
364	Comprehensive Medical Center PLLC	Royal Oak	Michigan	United States	48073
365	Hematology Oncology Consultants PC-Royal Oak	Royal Oak	Michigan	United States	48073
366	Oakland Medical Group	Royal Oak	Michigan	United States	48073
367	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan	United States	48073
368	Saint Mary's of Michigan	Saginaw	Michigan	United States	48601
369	Marie Yeager Cancer Center	Saint Joseph	Michigan	United States	49085
370	Providence Hospital - Southfield	Southfield	Michigan	United States	48075-9975
371	Premier Hematology Oncology Care	Sterling Heights	Michigan	United States	48312
372	Mitchell Folbe MD PC	Sterling Heights	Michigan	United States	48314
373	Munson Medical Center	Traverse City	Michigan	United States	49684
374	Michigan Institute of Urology-Town Center	Troy	Michigan	United States	48084
375	Claudia BR Herke MD PC	Troy	Michigan	United States	48085
376	Hematology Oncology Consultants PC-Troy	Troy	Michigan	United States	48098
377	William Beaumont Hospital - Troy	Troy	Michigan	United States	48098
378	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
379	Sanford Clinic North-Bemidji	Bemidji	Minnesota	United States	56601
380	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
381	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
382	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
383	Essentia Health Saint Mary's Medical Center	Duluth	Minnesota	United States	55805
384	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
385	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
386	Unity Hospital	Fridley	Minnesota	United States	55432
387	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
388	Mayo Clinic Health Systems-Mankato	Mankato	Minnesota	United States	56001
389	Minnesota Oncology - Maplewood	Maplewood	Minnesota	United States	55109
390	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
391	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55102
392	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
393	Minneapolis Veterans Medical Center	Minneapolis	Minnesota	United States	55417
394	Health Partners Inc	Minneapolis	Minnesota	United States	55454
395	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
396	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
397	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
398	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
399	Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
400	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
401	Regions Hospital	Saint Paul	Minnesota	United States	55101
402	United Hospital	Saint Paul	Minnesota	United States	55102
403	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
404	Lakeview Hospital	Stillwater	Minnesota	United States	55082
405	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
406	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
407	Minnesota Oncology - Woodbury	Woodbury	Minnesota	United States	55125
408	Gulfport Memorial Hospital	Gulfport	Mississippi	United States	39502
409	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
410	Singing River Hospital	Pascagoula	Mississippi	United States	39581
411	Central Care Cancer Center - Carrie J Babb Cancer Center	Bolivar	Missouri	United States	65613
412	Parkland Health Center-Bonne Terre	Bonne Terre	Missouri	United States	63628
413	Cox Cancer Center Branson	Branson	Missouri	United States	65616
414	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
415	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
416	University of Missouri - Ellis Fischel	Columbia	Missouri	United States	65212
417	Centerpoint Medical Center LLC	Independence	Missouri	United States	64057
418	Capital Region Medical Center-Goldschmidt Cancer Center	Jefferson City	Missouri	United States	65109
419	Freeman Health System	Joplin	Missouri	United States	64804
420	Mercy Hospital-Joplin	Joplin	Missouri	United States	64804
421	Truman Medical Center	Kansas City	Missouri	United States	64108
422	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
423	North Kansas City Hospital	Kansas City	Missouri	United States	64116
424	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri	United States	64118
425	Kansas City Cancer Centers - South	Kansas City	Missouri	United States	64131
426	Research Medical Center	Kansas City	Missouri	United States	64132
427	Kansas City Cancer Centers - North	Kansas City	Missouri	United States	64154
428	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
429	Liberty Radiation Oncology Center	Liberty	Missouri	United States	64068
430	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
431	Phelps County Regional Medical Center	Rolla	Missouri	United States	65401
432	Lakeland Hospital	Saint Joseph	Missouri	United States	49085
433	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
434	Saint Louis Cancer and Breast Institute - South City	Saint Louis	Missouri	United States	63109
435	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
436	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
437	Barnes-Jewish West County Hospital	Saint Louis	Missouri	United States	63141
438	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
439	Siteman Cancer Center - Saint Peters	Saint Peters	Missouri	United States	63376
440	Sainte Genevieve County Memorial Hospital	Sainte Genevieve	Missouri	United States	63670
441	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
442	Cox Health South Hospital	Springfield	Missouri	United States	65807
443	Missouri Baptist Sullivan Hospital	Sullivan	Missouri	United States	63080
444	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri	United States	63127
445	Montana Cancer Consortium NCORP	Billings	Montana	United States	59101
446	Saint Vincent Healthcare	Billings	Montana	United States	59101
447	Billings Clinic Cancer Center	Billings	Montana	United States	59107
448	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
449	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
450	Benefis Healthcare - Sletten Cancer Institute	Great Falls	Montana	United States	59405
451	Saint Peter's Community Hospital	Helena	Montana	United States	59601
452	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
453	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
454	CHI Health Saint Francis	Grand Island	Nebraska	United States	68803
455	Heartland Hematology and Oncology	Kearney	Nebraska	United States	68845
456	CHI Health Good Samaritan	Kearney	Nebraska	United States	68847
457	Nebraska Cancer Research Center	Lincoln	Nebraska	United States	68510
458	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
459	Great Plains Regional Medical Center	North Platte	Nebraska	United States	69101
460	Missouri Valley Cancer Consortium CCOP	Omaha	Nebraska	United States	68106
461	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
462	Oncology Hematology West, P.C.	Omaha	Nebraska	United States	68114
463	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
464	Hematology and Oncology Consultants PC	Omaha	Nebraska	United States	68122
465	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
466	Alegent Health Lakeside Hospital	Omaha	Nebraska	United States	68130
467	Creighton University Cancer Center	Omaha	Nebraska	United States	68131-2197
468	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
469	Midlands Community Hospital	Papillion	Nebraska	United States	68046
470	21st Century Oncology-Henderson	Henderson	Nevada	United States	89074
471	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
472	Cancer and Blood Specialists-Henderson	Las Vegas	Nevada	United States	89106
473	21st Century Oncology	Las Vegas	Nevada	United States	89109
474	HealthCare Partners Medical Group Oncology/Hematology-San Martin	Las Vegas	Nevada	United States	89113
475	Cancer Therapy and Integrative Medicine	Las Vegas	Nevada	United States	89121
476	21st Century Oncology-Vegas Tenaya	Las Vegas	Nevada	United States	89128
477	Cancer and Blood Specialists-Shadow	Las Vegas	Nevada	United States	89128
478	Cancer and Blood Specialists-Tenaya	Las Vegas	Nevada	United States	89128
479	HealthCare Partners Medical Group Oncology/Hematology-Tenaya	Las Vegas	Nevada	United States	89128
480	21st Century Oncology-Fort Apache	Las Vegas	Nevada	United States	89148
481	Cancer and Blood Specialists-Fort Apache	Las Vegas	Nevada	United States	89148
482	New Hampshire Oncology Hematology PA-Concord	Concord	New Hampshire	United States	03301
483	Wentworth Douglass Hospital	Dover	New Hampshire	United States	03820
484	New Hampshire Oncology-Hematology, PA - Hooksett	Hooksett	New Hampshire	United States	03106
485	LRGHealthcare-Lakes Region General Hospital	Laconia	New Hampshire	United States	03246
486	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
487	Norris Cotton Cancer Center-Manchester	Manchester	New Hampshire	United States	03102
488	Cooper Hospital University Medical Center	Camden	New Jersey	United States	08103
489	Veterans Administration New Jersey Health Care System	East Orange	New Jersey	United States	07018
490	Saint Barnabas Medical Center	Livingston	New Jersey	United States	07039
491	Monmouth Medical Center	Long Branch	New Jersey	United States	07740
492	Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County	Mount Holly	New Jersey	United States	08060
493	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
494	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey	United States	08876
495	Inspira Medical Center Vineland	Vineland	New Jersey	United States	08360
496	Virtua West Jersey Hospital Voorhees	Voorhees	New Jersey	United States	08043
497	Inspira Medical Center Woodbury	Woodbury	New Jersey	United States	08096
498	Lovelace Medical Center - Downtown	Albuquerque	New Mexico	United States	87102
499	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
500	Lovelace Medical Center at Lovelace Sandia Health System	Albuquerque	New Mexico	United States	87108
501	Memorial Medical Center-Las Cruces	Las Cruces	New Mexico	United States	88011
502	Albert Einstein College of Medicine	Bronx	New York	United States	10461
503	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
504	Elmhurst Hospital Center	Elmhurst	New York	United States	11373
505	Arnot Ogden Medical Center/Falck Cancer Center	Elmira	New York	United States	14905
506	Glens Falls Hospital	Glens Falls	New York	United States	12801
507	Queens Hospital Center	Jamaica	New York	United States	11432
508	North Shore University Hospital	Manhasset	New York	United States	11030
509	North Shore-LIJ Health System/Center for Advanced Medicine	New Hyde Park	New York	United States	11040
510	Beth Israel Medical Center	New York	New York	United States	10003
511	Saint Luke's Roosevelt Hospital Center - Saint Luke's Division	New York	New York	United States	10025
512	Weill Medical College of Cornell University	New York	New York	United States	10065
513	Rochester General Hospital	Rochester	New York	United States	14621
514	University of Rochester	Rochester	New York	United States	14642
515	Staten Island University Hospital	Staten Island	New York	United States	10305
516	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
517	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
518	Faxton-Saint Luke's Healthcare	Utica	New York	United States	13502
519	Randolph Hospital	Asheboro	North Carolina	United States	27203
520	Cancer Care of Western North Carolina	Asheville	North Carolina	United States	28801
521	Mission Hospital-Memorial Campus	Asheville	North Carolina	United States	28801
522	Mountain Radiation Oncology	Asheville	North Carolina	United States	28801
523	Hope Women's Cancer Centers-Asheville	Asheville	North Carolina	United States	28816
524	Transylvania Regional Hospital	Brevard	North Carolina	United States	28612
525	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
526	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	United States	28203
527	Southeastern Medical Oncology Center-Clinton	Clinton	North Carolina	United States	28328
528	Duke University Medical Center	Durham	North Carolina	United States	27710
529	Angel Medical Center	Franklin	North Carolina	United States	28744
530	Southeastern Medical Oncology Center-Goldsboro	Goldsboro	North Carolina	United States	27534
531	Wayne Memorial Hospital	Goldsboro	North Carolina	United States	27534
532	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
533	Park Ridge Health	Hendersonville	North Carolina	United States	28792
534	Maria Parham Medical Center	Henderson	North Carolina	United States	27536
535	Onslow Memorial Hospital	Jacksonville	North Carolina	United States	28546
536	Southeastern Medical Oncology Center-Jacksonville	Jacksonville	North Carolina	United States	28546
537	Kinston Medical Specialists PA	Kinston	North Carolina	United States	28501
538	Southeastern Regional Medical Center	Lumberton	North Carolina	United States	28359
539	McDowell Hospital	Marion	North Carolina	United States	28754
540	Rex Cancer Center	Raleigh	North Carolina	United States	27607
541	Duke Raleigh Hospital	Raleigh	North Carolina	United States	27609
542	Rex Cancer Center of Wakefield	Raleigh	North Carolina	United States	27614
543	Annie Penn Memorial Hospital	Reidsville	North Carolina	United States	27320
544	Blue Ridge Regional Hospital	Spruce Pine	North Carolina	United States	28777
545	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
546	New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28402-9025
547	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
548	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
549	Sanford Clinic North-Fargo	Fargo	North Dakota	United States	58102
550	Sanford Medical Center-Fargo	Fargo	North Dakota	United States	58122
551	Sanford Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
552	Trinity Cancer Care Center	Minot	North Dakota	United States	58701
553	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio	United States	44304
554	Akron General Medical Center	Akron	Ohio	United States	44307
555	Summa Barberton Hospital	Barberton	Ohio	United States	44203
556	Cleveland Clinic Cancer Center Beachwood	Beachwood	Ohio	United States	44122
557	Strecker Cancer Center-Belpre	Belpre	Ohio	United States	45714
558	Aultman Health Foundation	Canton	Ohio	United States	44710
559	Miami Valley Hospital South	Centerville	Ohio	United States	45459
560	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
561	Oncology Hematology Care Inc-Eden Park	Cincinnati	Ohio	United States	45202
562	Oncology Hematology Care Inc-Mercy West	Cincinnati	Ohio	United States	45211
563	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio	United States	45220
564	Oncology Hematology Care Inc-Anderson	Cincinnati	Ohio	United States	45230
565	Oncology Hematology Care Inc-Kenwood	Cincinnati	Ohio	United States	45236
566	Bethesda North Hospital	Cincinnati	Ohio	United States	45242
567	Oncology Hematology Care Inc-Blue Ash	Cincinnati	Ohio	United States	45242
568	TriHealth Cancer Institute-Westside	Cincinnati	Ohio	United States	45247
569	TriHealth Cancer Institute-Anderson	Cincinnati	Ohio	United States	45255
570	University of Cincinnati	Cincinnati	Ohio	United States	45267
571	Case Western Reserve Center	Cleveland	Ohio	United States	44106
572	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
573	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio	United States	44111
574	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
575	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
576	Mount Carmel Hospital East	Columbus	Ohio	United States	43213
577	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio	United States	43214
578	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
579	Columbus NCI Community Oncology Research Program	Columbus	Ohio	United States	43215
580	Grant Medical Center	Columbus	Ohio	United States	43215
581	The Mark H Zangmeister Center	Columbus	Ohio	United States	43219
582	Doctors Hospital	Columbus	Ohio	United States	43228
583	Good Samaritan Hospital - Dayton	Dayton	Ohio	United States	45406
584	Miami Valley Hospital	Dayton	Ohio	United States	45409
585	Dayton NCI Community Oncology Research Program	Dayton	Ohio	United States	45420
586	Veteran Affairs Medical Center	Dayton	Ohio	United States	45428
587	Delaware Health Center-Grady Cancer Center	Delaware	Ohio	United States	43015
588	Delaware Radiation Oncology	Delaware	Ohio	United States	43015
589	Grady Memorial Hospital	Delaware	Ohio	United States	43015
590	Oncology Hematology Care Inc-Healthplex	Fairfield	Ohio	United States	45014
591	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
592	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
593	Wayne Hospital	Greenville	Ohio	United States	45331
594	Cleveland Clinic Cancer Center Independence	Independence	Ohio	United States	44131
595	Kettering Medical Center	Kettering	Ohio	United States	45429
596	Fairfield Medical Center	Lancaster	Ohio	United States	43130
597	Cleveland Clinic Cancer Center Mansfield	Mansfield	Ohio	United States	44906
598	Marietta Memorial Hospital	Marietta	Ohio	United States	45750
599	Toledo Clinic Cancer Centers-Maumee	Maumee	Ohio	United States	43537-1839
600	Toledo Radiation Oncology at Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
601	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio	United States	44124
602	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
603	Newark Radiation Oncology	Newark	Ohio	United States	43055
604	Saint Charles Hospital	Oregon	Ohio	United States	43616
605	Southern Ohio Medical Center	Portsmouth	Ohio	United States	45662
606	North Coast Cancer Care	Sandusky	Ohio	United States	44870
607	Springfield Regional Medical Center	Springfield	Ohio	United States	45505
608	Trinity's Tony Teramana Cancer Center	Steubenville	Ohio	United States	43952
609	Cleveland Clinic Foundation - Strongsville	Strongsville	Ohio	United States	44136
610	Flower Hospital	Sylvania	Ohio	United States	43560
611	Toledo Clinic Cancer Centers-Toledo	Toledo	Ohio	United States	43623
612	Upper Valley Medical Center	Troy	Ohio	United States	45373
613	South Pointe Hospital	Warrensville Heights	Ohio	United States	44122
614	Saint Ann's Hospital	Westerville	Ohio	United States	43081
615	UHHS Westlake Medical Center	Westlake	Ohio	United States	44145
616	Cleveland Clinic - Wooster Specialty Center	Wooster	Ohio	United States	44691
617	Genesis Healthcare System Cancer Care Center	Zanesville	Ohio	United States	43701
618	Mercy Clinic Oklahoma Communities Inc-Norman	Norman	Oklahoma	United States	73071
619	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
620	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma	United States	73120
621	Tulsa Cancer Institute	Tulsa	Oklahoma	United States	74146
622	Saint Charles Health System	Bend	Oregon	United States	97701
623	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
624	Providence Oncology and Hematology Care Southeast	Clackamas	Oregon	United States	97015
625	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
626	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
627	Providence Willamette Falls Medical Center	Oregon City	Oregon	United States	97045
628	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon	United States	97210
629	Providence Portland Medical Center	Portland	Oregon	United States	97213
630	Providence Saint Vincent Medical Center	Portland	Oregon	United States	97225
631	Oregon Health and Science University	Portland	Oregon	United States	97239
632	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
633	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
634	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	United States	18103
635	UPMC-Heritage Valley Health System Beaver	Beaver	Pennsylvania	United States	15009
636	Saint Luke's University Hospital-Bethlehem Campus	Bethlehem	Pennsylvania	United States	18015
637	Lehigh Valley Hospital - Muhlenberg	Bethlehem	Pennsylvania	United States	18017
638	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
639	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
640	Easton Hospital	Easton	Pennsylvania	United States	18042
641	Adams Cancer Center	Gettysburg	Pennsylvania	United States	17325
642	UPMC Cancer Centers - Arnold Palmer Pavilion	Greensburg	Pennsylvania	United States	15601
643	Cherry Tree Cancer Center	Hanover	Pennsylvania	United States	17331
644	PinnacleHealth Regional Cancer Center at Polyclinic Hospital	Harrisburg	Pennsylvania	United States	17105
645	UPMC-Johnstown/John P. Murtha Regional Cancer Center	Johnstown	Pennsylvania	United States	15901
646	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
647	UPMC Cancer Center at UPMC McKeesport	McKeesport	Pennsylvania	United States	15132
648	Forbes Hospital	Monroeville	Pennsylvania	United States	15146
649	UPMC-Coraopolis/Heritage Valley Radiation Oncology	Moon	Pennsylvania	United States	15108
650	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301
651	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
652	UPMC-Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
653	UPMC-Presbyterian Hospital	Pittsburgh	Pennsylvania	United States	15213
654	UPMC-Saint Margaret	Pittsburgh	Pennsylvania	United States	15215
655	West Penn Hospital	Pittsburgh	Pennsylvania	United States	15224
656	University of Pittsburgh Cancer Institute (UPCI)	Pittsburgh	Pennsylvania	United States	15232
657	UPMC-Shadyside Hospital	Pittsburgh	Pennsylvania	United States	15232
658	UPMC Jefferson Regional Radiation Oncology	Pittsburgh	Pennsylvania	United States	15236
659	UPMC-Passavant Hospital	Pittsburgh	Pennsylvania	United States	15237
660	UPMC-Saint Clair Hospital Cancer Center	Pittsburgh	Pennsylvania	United States	15243
661	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania	United States	19464
662	Geisinger Medical Oncology-Pottsville	Pottsville	Pennsylvania	United States	17901
663	Scranton Hematology-Oncology	Scranton	Pennsylvania	United States	18510
664	Grand View Hospital	Sellersville	Pennsylvania	United States	18960
665	UPMC Cancer Center at UPMC Northwest	Seneca	Pennsylvania	United States	16346
666	Geisinger Medical Group	State College	Pennsylvania	United States	16801
667	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
668	UPMC Uniontown Hospital Radiation Oncology	Uniontown	Pennsylvania	United States	15401
669	UPMC Washington Hospital Radiation Oncology	Washington	Pennsylvania	United States	15301
670	Chester County Hospital	West Chester	Pennsylvania	United States	19380
671	Jennersville Regional Hospital	West Grove	Pennsylvania	United States	19390-9499
672	Reading Hospital	West Reading	Pennsylvania	United States	19611
673	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
674	Susquehanna Cancer Center at Divine Providence Hospital	Williamsport	Pennsylvania	United States	17701
675	Wellspan Health - York Cancer Center	York	Pennsylvania	United States	17403
676	WellSpan Health-York Hospital	York	Pennsylvania	United States	17405
677	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island	United States	02860
678	Rhode Island Hospital	Providence	Rhode Island	United States	02903
679	Miriam Hospital	Providence	Rhode Island	United States	02906
680	AnMed Health Cancer Center	Anderson	South Carolina	United States	29621
681	Medical University of South Carolina	Charleston	South Carolina	United States	29425
682	Greenville Health System Cancer Institute-Easley	Easley	South Carolina	United States	29640
683	Greenville Health System Cancer Institute - Butternut	Greenville	South Carolina	United States	29605
684	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina	United States	29605
685	Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
686	Saint Francis Cancer Center	Greenville	South Carolina	United States	29607
687	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina	United States	29615
688	Greenville Health System Cancer Institute-Greer	Greer	South Carolina	United States	29650
689	Gibbs Cancer Center-Pelham	Greer	South Carolina	United States	29651
690	Carolina Blood and Cancer Care Associates, PA	Lancaster	South Carolina	United States	29720
691	Carolina Blood and Cancer Care	Rock Hill	South Carolina	United States	29732
692	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina	United States	29672
693	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
694	Greenville Health System Cancer Institute - Spartanburg	Spartanburg	South Carolina	United States	29307
695	Avera Saint Luke's Hospital and Cancer Center	Aberdeen	South Dakota	United States	57401
696	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
697	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota	United States	57104
698	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
699	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117
700	Wellmont Medical Associates-Oncology and Hematology	Bristol	Tennessee	United States	37620
701	Pulmonary Medicine Center of Chattanooga-Hixson	Hixson	Tennessee	United States	37343
702	Wellmont Holston Valley Hospital and Medical Center	Kingsport	Tennessee	United States	37660
703	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
704	University of Tennessee - Knoxville	Knoxville	Tennessee	United States	37920
705	Tennessee Oncology PLLC- Centennial Medical Center	Nashville	Tennessee	United States	37203
706	Memorial GYN Plus	Ooltewah	Tennessee	United States	37363
707	Lyndon Baines Johnson General Hospital	Houston	Texas	United States	77026
708	Baylor College of Medicine	Houston	Texas	United States	77030
709	Ben Taub General Hospital	Houston	Texas	United States	77030
710	M D Anderson Cancer Center	Houston	Texas	United States	77030
711	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
712	University Hospital - San Antonio	San Antonio	Texas	United States	78229
713	Scott and White Memorial Hospital	Temple	Texas	United States	76508
714	Central Vermont Medical Center	Berlin	Vermont	United States	05602
715	University of Vermont College of Medicine	Burlington	Vermont	United States	05405
716	Norris Cotton Cancer Center-North	Saint Johnsbury	Vermont	United States	05819
717	White River Junction Veteran Administration Medical Center	White River Junction	Vermont	United States	05009
718	Medical Oncology Hematology Associates of Northern Virginia Limited	Fairfax	Virginia	United States	22031
719	Virginia Oncology Associates - Hampton	Hampton	Virginia	United States	23666
720	Memorial Hospital Of Martinsville	Martinsville	Virginia	United States	24115
721	Bon Secours Saint Francis Medical Center	Midlothian	Virginia	United States	23114
722	Southwest VA Regional Cancer Center	Norton	Virginia	United States	24273
723	Bon Secours Saint Mary's Hospital	Richmond	Virginia	United States	23226
724	Virginia Cancer Institute - West End	Richmond	Virginia	United States	23230
725	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
726	VCU Community Memorial Health Center	South Hill	Virginia	United States	23970
727	Cancer Care Center at Island Hospital	Anacortes	Washington	United States	98221
728	MultiCare Auburn Medical Center	Auburn	Washington	United States	98001
729	Virginia Mason Bainbridge Island Medical Center	Bainbridge Island	Washington	United States	98110
730	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
731	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	United States	98225
732	Harrison HealthPartners Hematology and Oncology-Bremerton	Bremerton	Washington	United States	98310
733	Harrison Medical Center	Bremerton	Washington	United States	98310
734	Highline Medical Center-Main Campus	Burien	Washington	United States	98166
735	Swedish Medical Center-Edmonds	Edmonds	Washington	United States	98026
736	Saint Elizabeth Hospital	Enumclaw	Washington	United States	98022
737	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
738	Virginia Mason Federal Way Medical Center	Federal Way	Washington	United States	98002
739	Saint Francis Hospital	Federal Way	Washington	United States	98003
740	Tacoma/Valley Radiation Oncology Centers-Gig Harbor	Gig Harbor	Washington	United States	98332
741	MultiCare Gig Harbor Medical Park	Gig Harbor	Washington	United States	98335
742	Swedish Cancer Institute-Issaquah	Issaquah	Washington	United States	98029
743	Kadlec Clinic Hematology and Oncology	Kennewick	Washington	United States	99336
744	Northwest Cancer Clinic	Kennewick	Washington	United States	99336
745	Seattle Cancer Care Alliance at EvergreenHealth	Kirkland	Washington	United States	98034
746	Saint Clare Hospital	Lakewood	Washington	United States	98499
747	Saint John Medical Center	Longview	Washington	United States	98632
748	Virginia Mason Lynnwood Medical Center	Lynnwood	Washington	United States	98036
749	Skagit Valley Hospital	Mount Vernon	Washington	United States	98274
750	Harrison HealthPartners Hematology and Oncology-Poulsbo	Poulsbo	Washington	United States	98370
751	Peninsula Cancer Center	Poulsbo	Washington	United States	98370
752	MultiCare Good Samaritan Hospital	Puyallup	Washington	United States	98372
753	Tacoma/Valley Radiation Oncology Centers-Puyallup	Puyallup	Washington	United States	98372
754	Virginia Mason Medical Center	Seattle	Washington	United States	98101
755	Minor and James Medical PLLC	Seattle	Washington	United States	98104
756	Swedish Medical Center-Ballard Campus	Seattle	Washington	United States	98107
757	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
758	Group Health Cooperative-Seattle	Seattle	Washington	United States	98112
759	Swedish Medical Center-First Hill	Seattle	Washington	United States	98122
760	University of Washington Medical Center	Seattle	Washington	United States	98195
761	Cancer Care Northwest-North Spokane	Spokane	Washington	United States	98109
762	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
763	Cancer Care Northwest-Valley	Spokane	Washington	United States	99216
764	Evergreen Hematology and Oncology PS	Spokane	Washington	United States	99218
765	Tacoma/Valley Radiation Oncology Centers-Jackson Hall	Tacoma	Washington	United States	97405
766	Franciscan Research Center - Northwest Medical Plaza	Tacoma	Washington	United States	98405
767	Northwest Medical Specialties PLLC	Tacoma	Washington	United States	98405
768	Northwest NCI Community Oncology Research Program	Tacoma	Washington	United States	98405
769	Tacoma/Valley Radiation Oncology Centers-Saint Joe's	Tacoma	Washington	United States	98405
770	Multicare Health System	Tacoma	Washington	United States	98415
771	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
772	PeaceHealth Southwest Medical Center	Vancouver	Washington	United States	98664
773	Legacy Salmon Creek Hospital	Vancouver	Washington	United States	98686
774	Wenatchee Valley Hospital and Clinics	Wenatchee	Washington	United States	98801
775	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
776	Edwards Comprehensive Cancer Center	Huntington	West Virginia	United States	25701
777	Princeton Community Hospital	Princeton	West Virginia	United States	24740
778	Fox Valley Hematology and Oncology	Appleton	Wisconsin	United States	54911-3496
779	Aurora Cancer Care-Burlington	Burlington	Wisconsin	United States	53105
780	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin	United States	54701
781	Mayo Clinic Health System-Eau Claire Clinic	Eau Claire	Wisconsin	United States	54701
782	Mayo Clinic Health System Eau Claire Hospital-Luther Campus	Eau Claire	Wisconsin	United States	54703
783	Aurora Cancer Care-Southern Lakes	Elkhorn	Wisconsin	United States	53121
784	Aurora Cancer Care-Grafton	Grafton	Wisconsin	United States	53024
785	Green Bay Oncology at Saint Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
786	Saint Vincent Hospital	Green Bay	Wisconsin	United States	54301
787	Green Bay Oncology Limited at Saint Mary's Hospital	Green Bay	Wisconsin	United States	54303
788	Saint Mary's Hospital	Green Bay	Wisconsin	United States	54303
789	Aurora BayCare Medical Center	Green Bay	Wisconsin	United States	54311
790	UW Cancer Center Johnson Creek	Johnson Creek	Wisconsin	United States	53038
791	Aurora Cancer Care-Kenosha South	Kenosha	Wisconsin	United States	53142
792	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
793	Holy Family Memorial Hospital	Manitowoc	Wisconsin	United States	54221
794	Bay Area Medical Center	Marinette	Wisconsin	United States	54143
795	Vince Lombardi Cancer Clinic - Marinette	Marinette	Wisconsin	United States	54143
796	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
797	Aurora Advanced Healthcare Inc-Menomonee Falls	Menomonee Falls	Wisconsin	United States	53051
798	Aurora Cancer Care-Milwaukee	Milwaukee	Wisconsin	United States	53209
799	Wheaton Franciscan Healthcare - St. Joseph	Milwaukee	Wisconsin	United States	53210
800	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
801	Aurora Sinai Medical Center	Milwaukee	Wisconsin	United States	53233
802	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
803	D N Greenwald Center	Mukwonago	Wisconsin	United States	53149
804	Westfields Hospital/Cancer Center of Western Wisconsin	New Richmond	Wisconsin	United States	54017
805	Oconomowoc Memorial Hospital-ProHealth Care Inc	Oconomowoc	Wisconsin	United States	53066
806	Green Bay Oncology - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
807	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin	United States	54904
808	Aurora Cancer Care-Racine	Racine	Wisconsin	United States	53406-5661
809	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin	United States	54501
810	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin	United States	54868
811	Saint Nicholas Hospital	Sheboygan	Wisconsin	United States	53081
812	Vince Lombardi Cancer Clinic - Sheboygan	Sheboygan	Wisconsin	United States	53081
813	Marshfield Clinic Cancer Care at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
814	Green Bay Oncology - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
815	Aurora Medical Center in Summit	Summit	Wisconsin	United States	53066
816	Vince Lombardi Cancer Clinic - Two Rivers	Two Rivers	Wisconsin	United States	54241
817	Aurora Cancer Care-Waukesha	Waukesha	Wisconsin	United States	53188
818	Waukesha Memorial Hospital	Waukesha	Wisconsin	United States	53188
819	Aspirus Regional Cancer Center	Wausau	Wisconsin	United States	54401
820	Aurora Cancer Care-Milwaukee West	Wauwatosa	Wisconsin	United States	53226
821	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227
822	Diagnostic and Treatment Center	Weston	Wisconsin	United States	54476
823	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
824	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
825	Cheyenne Regional Medical Center-West	Cheyenne	Wyoming	United States	82001
826	Welch Cancer Center	Sheridan	Wyoming	United States	82801
827	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
828	BCCA-Cancer Centre for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
829	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
830	Horizon Health Network-Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
831	Cambridge Memorial Hospital	Cambridge	Ontario	Canada	N1R 3G2
832	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6
833	Niagara Health System-Saint Catharines General	Saint Catharines	Ontario	Canada	ON L2S 0A9
834	Health Sciences North	Sudbury	Ontario	Canada	P3E 5J1
835	Toronto East General Hospital	Toronto	Ontario	Canada	M4C 3E7
836	Mount Sinai Hospital - Toronto	Toronto	Ontario	Canada	M5G 1X5
837	PEI Cancer Treatment Centre-Queen Elizabeth Hospital	Charlottetown	Prince Edward Island	Canada	C1A 8T5
838	McGill University Department of Oncology	Montreal	Quebec	Canada	H2W 1S6
839	Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec	Canada	J1H 5N4
840	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
841	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4
842	San Juan City Hospital	San Juan		Puerto Rico	00936

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: Jeffrey Meyerhardt, MD, MPH, Dana-Farber Cancer Institute

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Feb 24, 2021

More Information

Additional Information:

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT01150045

Other Study ID Numbers:

CALGB-80702
U10CA031946
CALGB-80702
CDR0000675693

First Posted:

Jun 24, 2010

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Keywords provided by Alliance for Clinical Trials in Oncology

adenocarcinoma of the colon

stage III colon cancer

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	One patient withdrew from the trial before being randomized and was excluded from any analysis.

Arm/Group Title	Arm A - 12 Cycles of FOLFOX Plus Placebo Daily	Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily	Arm C - 6 Cycles of FOLFOX Plus Placebo Daily	Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily
Arm/Group Description	The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. > Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. > Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. > Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. > Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
Period Title: Overall Study
STARTED	615	647	646	618
COMPLETED	615	646	646	617
NOT COMPLETED	0	1	0	1

Baseline Characteristics

Arm/Group Title	Arm A - FOLFOX and Placebo (12 Treatments)	Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily	Arm C - 6 Cycles of FOLFOX Plus Placebo Daily	Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily	Total
Arm/Group Description	The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil.> Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	Total of all reporting groups
Overall Participants	615	646	646	617	2524
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61.0	61.9	61.0	61.5	61.3
Sex: Female, Male (Count of Participants)
Female	265 43.1%	297 46%	296 45.8%	276 44.7%	1134 44.9%
Male	350 56.9%	349 54%	350 54.2%	341 55.3%	1390 55.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	42 6.8%	45 7%	55 8.5%	49 7.9%	191 7.6%
Not Hispanic or Latino	559 90.9%	586 90.7%	571 88.4%	552 89.5%	2268 89.9%
Unknown or Not Reported	14 2.3%	15 2.3%	20 3.1%	16 2.6%	65 2.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.5%	5 0.8%	3 0.5%	4 0.6%	15 0.6%
Asian	22 3.6%	32 5%	21 3.3%	32 5.2%	107 4.2%
Native Hawaiian or Other Pacific Islander	0 0%	4 0.6%	2 0.3%	1 0.2%	7 0.3%
Black or African American	82 13.3%	88 13.6%	76 11.8%	73 11.8%	319 12.6%
White	487 79.2%	500 77.4%	522 80.8%	488 79.1%	1997 79.1%
More than one race	1 0.2%	2 0.3%	3 0.5%	0 0%	6 0.2%
Unknown or Not Reported	20 3.3%	15 2.3%	19 2.9%	19 3.1%	73 2.9%
Region of Enrollment (participants) [Number]
Canada	57 9.3%	44 6.8%	70 10.8%	61 9.9%	232 9.2%
United States	558 90.7%	602 93.2%	576 89.2%	556 90.1%	2292 90.8%

Outcome Measures

1. Primary Outcome

Title	Disease-free Survival
Description	Disease-Free Survival (DFS) is defined as the time of randomization until documented progression or death from any cause. The endpoint of this trial is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive and disease free after 3 years are reported here. A log-rank test stratified with the stratification factors was used to compare disease-free survival (celecoxib vs placebo)
Time Frame	At 3 years of follow-up

Outcome Measure Data

Analysis Population Description
All patients that were randomized and evaluable were included in this analysis.

Arm/Group Title	FOLFOX and Placebo (Arms A +C)	FOLFOX Plus Celecoxib Daily (Arms B + D)
Arm/Group Description	Arm A The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity. Arm C The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	Arm B The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity. Arm D The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
Measure Participants	1261	1263
Number (95% Confidence Interval) [percentage of participants]	73.4 11.9%	76.3 11.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FOLFOX and Placebo (Arms A +C)
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Log Rank
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95% 0.76 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Overall Survival
Description	Overall Survival (DFS) is defined as the time of randomization until documented death from any cause. The endpoint is to compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 5 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive after 3 years are reported here.
Time Frame	up to 3 years from registration

Outcome Measure Data

Analysis Population Description
All patients that were randomized and evaluable were included in this analysis.

Arm/Group Title	FOLFOX and Placebo (Arms A +C)	FOLFOX Plus Celecoxib Daily (Arms B + D)
Arm/Group Description	Arm A The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity. Arm C The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.	Arm B The FOLFOX regimen consisted of every 2 weeks cycles for 12 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity. Arm D The FOLFOX regimen consisted of every 2 weeks cycles for 6 cycles of 2-hour infusions of oxaliplatin at 85 mg/m2 and leucovorin at 400 mg/m2, followed by a bolus infusion of 400-mg/m2 of fluorouracil following by 46-48-hour continuous infusion of 2400-mg/m2 of fluorouracil. Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
Measure Participants	1261	1263
Number (95% Confidence Interval) [percentage of participants]	81.6 13.3%	84.3 13%

Adverse Events

	Arm A - FOLFOX and Placebo (12 Treatments)		Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily		Arm C - 6 Cycles of FOLFOX Plus Placebo Daily		Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily
Time Frame	Adverse events were collected after every 2-week cycle during treatment (up to 12 cycles or 24 weeks of treatment).
Adverse Event Reporting Description

Arm/Group Title	Arm A - FOLFOX and Placebo (12 Treatments)		Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily		Arm C - 6 Cycles of FOLFOX Plus Placebo Daily		Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily
Arm/Group Description	Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.		Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.		Placebo was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Placebo was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.		Celecoxib was dosed at 400 mg orally daily, starting by day 1 of the second treatment of FOLFOX. Celecoxib was administered daily for 3 years from the date of initiation of the first dose or until recurrence of disease or unacceptable toxicity.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/615 (1.6%)		8/647 (1.2%)		10/646 (1.5%)		9/618 (1.5%)
Serious Adverse Events
	Arm A - FOLFOX and Placebo (12 Treatments)		Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily		Arm C - 6 Cycles of FOLFOX Plus Placebo Daily		Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	77/615 (12.5%)		93/647 (14.4%)		72/646 (11.1%)		78/618 (12.6%)
Blood and lymphatic system disorders
Blood disorder	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Febrile neutropenia	1/615 (0.2%)	1	1/647 (0.2%)	1	2/646 (0.3%)	2	3/618 (0.5%)	4
Hemoglobin decreased	3/615 (0.5%)	3	5/647 (0.8%)	5	6/646 (0.9%)	6	6/618 (1%)	6
Hemolysis	3/615 (0.5%)	4	3/647 (0.5%)	5	2/646 (0.3%)	2	7/618 (1.1%)	7
Spleen disorder	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Cardiac disorders
Arrhythmia	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Arrhythmia supraventricular	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Asystole	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Atrial fibrillation	2/615 (0.3%)	2	2/647 (0.3%)	2	2/646 (0.3%)	2	2/618 (0.3%)	2
Cardiac disorder	0/615 (0%)	0	3/647 (0.5%)	3	3/646 (0.5%)	3	2/618 (0.3%)	2
Cardiac pain	1/615 (0.2%)	2	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Cardiac valve disease	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Cardiopulmonary arrest	1/615 (0.2%)	1	2/647 (0.3%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Conduction disorder	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Left ventricular dysfunction	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Left ventricular failure	2/615 (0.3%)	3	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Myocardial ischemia	5/615 (0.8%)	5	11/647 (1.7%)	11	9/646 (1.4%)	9	7/618 (1.1%)	7
Palpitations	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Restrictive cardiomyopathy	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Sinus bradycardia	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Sinus tachycardia	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Supraventricular tachycardia	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Ear and labyrinth disorders
Hearing impaired	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Eye disorders
Eye disorder	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Optic nerve disorder	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Vision blurred	0/615 (0%)	0	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Gastrointestinal disorders
Abdominal distension	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Abdominal pain	1/615 (0.2%)	1	2/647 (0.3%)	2	3/646 (0.5%)	3	8/618 (1.3%)	8
Anal mucositis (clin exam)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Colitis	0/615 (0%)	0	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Colonic obstruction	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	1/618 (0.2%)	1
Colonic perforation	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Constipation	1/615 (0.2%)	1	0/647 (0%)	0	2/646 (0.3%)	2	1/618 (0.2%)	1
Diarrhea	27/615 (4.4%)	33	33/647 (5.1%)	35	24/646 (3.7%)	25	12/618 (1.9%)	13
Dry mouth	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Duodenal ulcer	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Dysphagia	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Enteritis	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Gastric hemorrhage	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Gastric ulcer	1/615 (0.2%)	1	0/647 (0%)	0	3/646 (0.5%)	3	0/618 (0%)	0
Gastritis	2/615 (0.3%)	2	3/647 (0.5%)	4	4/646 (0.6%)	4	1/618 (0.2%)	1
Gastrointestinal disorder	1/615 (0.2%)	1	1/647 (0.2%)	1	2/646 (0.3%)	2	1/618 (0.2%)	1
Hemorrhoids	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Ileal perforation	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Ileus	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Lower gastrointestinal hemorrhage	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Mucositis oral (clin exam)	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Mucositis oral (funct/sympt)	1/615 (0.2%)	2	1/647 (0.2%)	1	1/646 (0.2%)	1	2/618 (0.3%)	2
Nausea	23/615 (3.7%)	28	22/647 (3.4%)	24	27/646 (4.2%)	29	20/618 (3.2%)	20
Pancreatic necrosis	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Pancreatitis	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Rectal hemorrhage	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Rectal mucositis (clin exam)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Salivary gland disorder	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Small intestinal mucositis (clin exam)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Small intestinal obstruction	4/615 (0.7%)	4	1/647 (0.2%)	1	2/646 (0.3%)	2	3/618 (0.5%)	3
Small intestinal perforation	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Upper gastrointestinal hemorrhage	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Vomiting	13/615 (2.1%)	15	10/647 (1.5%)	12	17/646 (2.6%)	17	8/618 (1.3%)	8
General disorders
Chest pain	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Chills	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Death NOS	4/615 (0.7%)	4	0/647 (0%)	0	0/646 (0%)	0	5/618 (0.8%)	5
Edema limbs	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Fatigue	41/615 (6.7%)	47	50/647 (7.7%)	56	29/646 (4.5%)	32	30/618 (4.9%)	30
Fever	1/615 (0.2%)	1	1/647 (0.2%)	1	3/646 (0.5%)	3	0/618 (0%)	0
Flu-like symptoms	0/615 (0%)	0	0/647 (0%)	0	2/646 (0.3%)	2	0/618 (0%)	0
Gait abnormal	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
General symptom	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Multi-organ failure	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Pain	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Sudden death	0/615 (0%)	0	0/647 (0%)	0	2/646 (0.3%)	2	1/618 (0.2%)	1
Hepatobiliary disorders
Cholecystitis	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Gallbladder fistula	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Hepatobiliary disease	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Immune system disorders
Hypersensitivity	2/615 (0.3%)	2	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Infections and infestations
Abdominal infection	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Bladder infection(gr 0/1/2 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Bone infection(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Catheter related infection(gr 0/1/2 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Encephalitis infection(unknown ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Gallbladder infection(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Infection(gr 0/1/2 ANC)	1/615 (0.2%)	1	2/647 (0.3%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Infectious colitis(gr 0/1/2 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Infectious colitis(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Pharyngitis(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Pneumonia(gr 3/4 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Pneumonia(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Sepsis(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Sepsis(gr 3/4 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Sepsis(unknown ANC)	1/615 (0.2%)	1	1/647 (0.2%)	1	1/646 (0.2%)	1	1/618 (0.2%)	1
Skin infection	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Soft tissue infection(gr 0/1/2 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Soft tissue infection(unknown ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Upper respiratory infection(unknown ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Urethral infection(gr 3/4 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Urinary tract infection(gr 3/4 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Wound infection	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Wound infection(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Injury, poisoning and procedural complications
Aortic injury	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Fracture	1/615 (0.2%)	2	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Intestinal stoma obstruction	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Intraoperative breast injury	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Vascular access complication	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	1/618 (0.2%)	1
Investigations
Alanine aminotransferase increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Alkaline phosphatase increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Amylase increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Aspartate aminotransferase increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	3/618 (0.5%)	5
Blood bilirubin increased	0/615 (0%)	0	1/647 (0.2%)	1	2/646 (0.3%)	2	1/618 (0.2%)	1
Cardiac troponin I increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Creatinine increased	11/615 (1.8%)	13	15/647 (2.3%)	15	11/646 (1.7%)	12	11/618 (1.8%)	11
Electrocardiogram QTc interval prolonged	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
INR increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Laboratory test abnormal	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Leukocyte count decreased	3/615 (0.5%)	3	4/647 (0.6%)	4	4/646 (0.6%)	4	2/618 (0.3%)	2
Lipase increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Lymphocyte count decreased	0/615 (0%)	0	2/647 (0.3%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Neutrophil count decreased	21/615 (3.4%)	23	26/647 (4%)	30	16/646 (2.5%)	18	17/618 (2.8%)	18
Platelet count decreased	25/615 (4.1%)	27	36/647 (5.6%)	41	20/646 (3.1%)	21	8/618 (1.3%)	9
Weight gain	0/615 (0%)	0	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Weight loss	0/615 (0%)	0	1/647 (0.2%)	1	2/646 (0.3%)	2	0/618 (0%)	0
Metabolism and nutrition disorders
Acidosis	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Anorexia	5/615 (0.8%)	7	1/647 (0.2%)	1	2/646 (0.3%)	2	1/618 (0.2%)	1
Blood glucose increased	4/615 (0.7%)	4	8/647 (1.2%)	9	5/646 (0.8%)	5	5/618 (0.8%)	5
Dehydration	7/615 (1.1%)	9	7/647 (1.1%)	7	6/646 (0.9%)	6	2/618 (0.3%)	2
Glucose intolerance	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Obesity	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Serum albumin decreased	1/615 (0.2%)	1	0/647 (0%)	0	3/646 (0.5%)	3	4/618 (0.6%)	4
Serum calcium decreased	3/615 (0.5%)	3	0/647 (0%)	0	3/646 (0.5%)	3	1/618 (0.2%)	1
Serum glucose decreased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Serum magnesium decreased	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Serum magnesium increased	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Serum phosphate decreased	1/615 (0.2%)	1	0/647 (0%)	0	2/646 (0.3%)	2	1/618 (0.2%)	1
Serum potassium decreased	5/615 (0.8%)	6	4/647 (0.6%)	4	3/646 (0.5%)	3	4/618 (0.6%)	4
Serum potassium increased	0/615 (0%)	0	1/647 (0.2%)	1	1/646 (0.2%)	1	1/618 (0.2%)	1
Serum sodium decreased	1/615 (0.2%)	1	4/647 (0.6%)	4	1/646 (0.2%)	1	1/618 (0.2%)	1
Serum sodium increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Back pain	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Bone pain	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Muscle weakness	0/615 (0%)	0	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Musculoskeletal disorder	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Pain in extremity	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Nervous system disorders
Ataxia	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Cognitive disturbance	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Depressed level of consciousness	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Dizziness	1/615 (0.2%)	1	3/647 (0.5%)	5	0/646 (0%)	0	1/618 (0.2%)	1
Dysgeusia	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Headache	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Intracranial hemorrhage	0/615 (0%)	0	0/647 (0%)	0	2/646 (0.3%)	2	1/618 (0.2%)	1
Ischemia cerebrovascular	4/615 (0.7%)	4	0/647 (0%)	0	2/646 (0.3%)	2	2/618 (0.3%)	2
Memory impairment	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Neurological disorder NOS	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Peripheral motor neuropathy	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Peripheral sensory neuropathy	49/615 (8%)	59	54/647 (8.3%)	64	35/646 (5.4%)	38	32/618 (5.2%)	34
Radiculitis brachial	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Syncope	1/615 (0.2%)	1	3/647 (0.5%)	3	1/646 (0.2%)	1	1/618 (0.2%)	1
Psychiatric disorders
Agitation	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Anxiety	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Confusion	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	2/618 (0.3%)	2
Depression	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	2/618 (0.3%)	2
Insomnia	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Personality change	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Psychosis	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Renal and urinary disorders
Bladder pain	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Glomerular filtration rate decreased	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Renal failure	3/615 (0.5%)	3	2/647 (0.3%)	2	1/646 (0.2%)	1	2/618 (0.3%)	2
Urogenital disorder	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Aspiration	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Cough	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	2
Dyspnea	3/615 (0.5%)	3	4/647 (0.6%)	4	0/646 (0%)	0	1/618 (0.2%)	1
Hiccups	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Hypoxia	2/615 (0.3%)	2	3/647 (0.5%)	3	1/646 (0.2%)	1	0/618 (0%)	0
Pleural effusion	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Pneumonitis	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Respiratory disorder	3/615 (0.5%)	3	4/647 (0.6%)	4	3/646 (0.5%)	3	0/618 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Dry skin	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Hand-and-foot syndrome/reaction	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Nail disorder	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Pain of skin	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Pruritus	1/615 (0.2%)	1	1/647 (0.2%)	2	0/646 (0%)	0	0/618 (0%)	0
Rash acneiform	0/615 (0%)	0	1/647 (0.2%)	2	0/646 (0%)	0	0/618 (0%)	0
Rash desquamating	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Skin disorder	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Skin hyperpigmentation	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Vascular disorders
Hemorrhage	0/615 (0%)	0	1/647 (0.2%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Hypertension	13/615 (2.1%)	13	17/647 (2.6%)	18	16/646 (2.5%)	18	16/618 (2.6%)	21
Hypotension	1/615 (0.2%)	1	1/647 (0.2%)	1	2/646 (0.3%)	2	1/618 (0.2%)	1
Peripheral ischemia	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Phlebitis	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Thrombosis	8/615 (1.3%)	8	12/647 (1.9%)	12	8/646 (1.2%)	17	2/618 (0.3%)	2
Vascular disorder	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm A - FOLFOX and Placebo (12 Treatments)		Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily		Arm C - 6 Cycles of FOLFOX Plus Placebo Daily		Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	574/615 (93.3%)		615/647 (95.1%)		618/646 (95.7%)		589/618 (95.3%)
Blood and lymphatic system disorders
Blood disorder	1/615 (0.2%)	1	4/647 (0.6%)	27	4/646 (0.6%)	15	3/618 (0.5%)	5
Bone marrow hypocellular	1/615 (0.2%)	3	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Febrile neutropenia	9/615 (1.5%)	11	12/647 (1.9%)	14	17/646 (2.6%)	18	15/618 (2.4%)	17
Hemoglobin decreased	13/615 (2.1%)	33	23/647 (3.6%)	51	10/646 (1.5%)	15	18/618 (2.9%)	21
Hemolysis	63/615 (10.2%)	194	53/647 (8.2%)	158	49/646 (7.6%)	102	49/618 (7.9%)	108
Thrombotic microangiopathy	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Cardiac disorders
Arrhythmia	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Arrhythmia supraventricular	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Atrial fibrillation	2/615 (0.3%)	3	4/647 (0.6%)	4	6/646 (0.9%)	10	0/618 (0%)	0
Atrial flutter	0/615 (0%)	0	2/647 (0.3%)	6	1/646 (0.2%)	4	0/618 (0%)	0
Cardiac disorder	3/615 (0.5%)	4	2/647 (0.3%)	2	1/646 (0.2%)	1	1/618 (0.2%)	1
Cardiac pain	0/615 (0%)	0	1/647 (0.2%)	4	0/646 (0%)	0	2/618 (0.3%)	2
Cardiac valve disease	1/615 (0.2%)	1	2/647 (0.3%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Conduction disorder	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Left ventricular dysfunction	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Left ventricular failure	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Myocardial ischemia	3/615 (0.5%)	3	6/647 (0.9%)	7	4/646 (0.6%)	4	4/618 (0.6%)	5
Palpitations	0/615 (0%)	0	1/647 (0.2%)	7	2/646 (0.3%)	2	2/618 (0.3%)	4
Restrictive cardiomyopathy	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Sinus tachycardia	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Supraventricular tachycardia	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Ventricular tachycardia	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Ear and labyrinth disorders
Ear pain	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Hearing impaired	3/615 (0.5%)	11	2/647 (0.3%)	20	1/646 (0.2%)	7	1/618 (0.2%)	2
Middle ear inflammation	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Tinnitus	1/615 (0.2%)	10	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Endocrine disorders
Endocrine disorder	1/615 (0.2%)	6	1/647 (0.2%)	1	2/646 (0.3%)	2	1/618 (0.2%)	1
Hypothyroidism	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Eye disorders
Cataract	2/615 (0.3%)	2	0/647 (0%)	0	3/646 (0.5%)	9	1/618 (0.2%)	6
Dry eye syndrome	0/615 (0%)	0	1/647 (0.2%)	3	1/646 (0.2%)	1	1/618 (0.2%)	1
Eye disorder	1/615 (0.2%)	1	2/647 (0.3%)	3	1/646 (0.2%)	3	1/618 (0.2%)	1
Eye pain	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	3	0/618 (0%)	0
Optic nerve disorder	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	19	0/618 (0%)	0
Optic nerve edema	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Retinal detachment	0/615 (0%)	0	1/647 (0.2%)	1	1/646 (0.2%)	2	0/618 (0%)	0
Vision blurred	2/615 (0.3%)	2	2/647 (0.3%)	2	4/646 (0.6%)	14	4/618 (0.6%)	10
Vitreous hemorrhage	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Watering eyes	4/615 (0.7%)	4	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Gastrointestinal disorders
Abdominal distension	3/615 (0.5%)	21	1/647 (0.2%)	1	1/646 (0.2%)	2	1/618 (0.2%)	1
Abdominal pain	21/615 (3.4%)	30	21/647 (3.2%)	31	19/646 (2.9%)	26	21/618 (3.4%)	27
Anal pain	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Cheilitis	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Colitis	3/615 (0.5%)	3	2/647 (0.3%)	2	1/646 (0.2%)	1	2/618 (0.3%)	2
Colonic hemorrhage	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Colonic obstruction	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	3/618 (0.5%)	4
Colonic perforation	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Colonic ulcer	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Constipation	15/615 (2.4%)	24	11/647 (1.7%)	21	25/646 (3.9%)	51	21/618 (3.4%)	43
Diarrhea	339/615 (55.1%)	1107	361/647 (55.8%)	1252	353/646 (54.6%)	922	326/618 (52.8%)	857
Dry mouth	3/615 (0.5%)	4	3/647 (0.5%)	5	2/646 (0.3%)	8	0/618 (0%)	0
Duodenal hemorrhage	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Duodenal obstruction	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Duodenal ulcer	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Dyspepsia	5/615 (0.8%)	26	7/647 (1.1%)	9	6/646 (0.9%)	20	7/618 (1.1%)	19
Dysphagia	1/615 (0.2%)	2	2/647 (0.3%)	2	1/646 (0.2%)	1	2/618 (0.3%)	2
Enteritis	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Esophageal mucositis (clin exam)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Esophageal mucositis (funct/sympt)	1/615 (0.2%)	1	0/647 (0%)	0	3/646 (0.5%)	3	0/618 (0%)	0
Esophageal pain	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	3	0/618 (0%)	0
Esophagitis	1/615 (0.2%)	1	1/647 (0.2%)	1	1/646 (0.2%)	4	0/618 (0%)	0
Fecal incontinence	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	2
Flatulence	3/615 (0.5%)	9	1/647 (0.2%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Gastric hemorrhage	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Gastric mucositis (clin exam)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Gastric mucositis (funct/sympt)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Gastric ulcer	5/615 (0.8%)	9	13/647 (2%)	17	8/646 (1.2%)	9	9/618 (1.5%)	12
Gastritis	39/615 (6.3%)	70	40/647 (6.2%)	64	39/646 (6%)	63	42/618 (6.8%)	80
Gastrointestinal disorder	6/615 (1%)	7	8/647 (1.2%)	25	3/646 (0.5%)	4	7/618 (1.1%)	9
Gastrointestinal fistula	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Gastrointestinal pain	1/615 (0.2%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Hemorrhoids	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Ileal perforation	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Ileus	1/615 (0.2%)	1	2/647 (0.3%)	2	1/646 (0.2%)	1	3/618 (0.5%)	3
Jejunal obstruction	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Large intestinal mucositis (funct/sympt)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Lower gastrointestinal hemorrhage	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Malabsorption	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Mucositis oral (clin exam)	6/615 (1%)	6	2/647 (0.3%)	2	2/646 (0.3%)	2	5/618 (0.8%)	5
Mucositis oral (funct/sympt)	12/615 (2%)	16	17/647 (2.6%)	25	8/646 (1.2%)	11	9/618 (1.5%)	10
Nausea	375/615 (61%)	1151	395/647 (61.1%)	1240	393/646 (60.8%)	857	360/618 (58.3%)	844
Oral hemorrhage	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Oral pain	2/615 (0.3%)	3	2/647 (0.3%)	4	2/646 (0.3%)	3	2/618 (0.3%)	4
Pancreatitis	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Periodontal disease	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Proctitis	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	2
Rectal hemorrhage	0/615 (0%)	0	3/647 (0.5%)	5	4/646 (0.6%)	5	2/618 (0.3%)	2
Rectal mucositis (clin exam)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Rectal pain	0/615 (0%)	0	2/647 (0.3%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Salivary gland disorder	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Small intestinal obstruction	4/615 (0.7%)	5	4/647 (0.6%)	4	3/646 (0.5%)	4	4/618 (0.6%)	4
Stomach pain	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	1/618 (0.2%)	1
Tooth disorder	0/615 (0%)	0	1/647 (0.2%)	3	0/646 (0%)	0	0/618 (0%)	0
Toothache	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Vomiting	164/615 (26.7%)	271	167/647 (25.8%)	283	143/646 (22.1%)	204	118/618 (19.1%)	195
General disorders
Chest pain	1/615 (0.2%)	3	3/647 (0.5%)	3	3/646 (0.5%)	3	0/618 (0%)	0
Chills	2/615 (0.3%)	2	1/647 (0.2%)	1	1/646 (0.2%)	2	1/618 (0.2%)	1
Edema limbs	8/615 (1.3%)	14	10/647 (1.5%)	38	9/646 (1.4%)	15	7/618 (1.1%)	8
Facial pain	0/615 (0%)	0	1/647 (0.2%)	1	3/646 (0.5%)	6	0/618 (0%)	0
Fatigue	471/615 (76.6%)	2400	500/647 (77.3%)	2649	491/646 (76%)	1972	456/618 (73.8%)	1723
Fever	5/615 (0.8%)	5	0/647 (0%)	0	0/646 (0%)	0	3/618 (0.5%)	3
Flu-like symptoms	2/615 (0.3%)	2	0/647 (0%)	0	2/646 (0.3%)	4	4/618 (0.6%)	6
Gait abnormal	1/615 (0.2%)	1	2/647 (0.3%)	8	0/646 (0%)	0	2/618 (0.3%)	2
General symptom	1/615 (0.2%)	3	2/647 (0.3%)	3	1/646 (0.2%)	6	2/618 (0.3%)	2
Hypothermia	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	2
Ill-defined disorder	1/615 (0.2%)	1	2/647 (0.3%)	2	0/646 (0%)	0	2/618 (0.3%)	3
Injection site reaction	0/615 (0%)	0	0/647 (0%)	0	2/646 (0.3%)	2	0/618 (0%)	0
Localized edema	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Pain	11/615 (1.8%)	17	12/647 (1.9%)	20	14/646 (2.2%)	22	14/618 (2.3%)	22
Hepatobiliary disorders
Cholecystitis	1/615 (0.2%)	1	0/647 (0%)	0	2/646 (0.3%)	2	1/618 (0.2%)	1
Gallbladder pain	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Hepatobiliary disease	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	9
Immune system disorders
Cytokine release syndrome	2/615 (0.3%)	2	2/647 (0.3%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Hypersensitivity	12/615 (2%)	13	7/647 (1.1%)	8	5/646 (0.8%)	5	7/618 (1.1%)	9
Immune system disorder	2/615 (0.3%)	5	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Infections and infestations
Abdominal infection	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Abdominal infection(gr 3/4 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Anorectal infection(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Bladder infection(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Bladder infection(gr 3/4 ANC)	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Bladder infection(unknown ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Bone infection(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Bone infection(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Bronchitis(gr 3/4 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Bronchitis(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	2	0/646 (0%)	0	0/618 (0%)	0
Catheter related infection	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Catheter related infection(gr 3/4 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Colitis, infectious	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Conjunctivitis	2/615 (0.3%)	3	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Device related infection(unknown ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Duodenal infection(gr 3/4 ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Endocarditis infective(gr 3/4 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Gallbladder infection(gr 3/4 ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Infection(gr 0/1/2 ANC)	4/615 (0.7%)	4	6/647 (0.9%)	8	4/646 (0.6%)	5	4/618 (0.6%)	4
Infectious colitis(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Infectious colitis(gr 3/4 ANC)	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	1/618 (0.2%)	1
Infectious meningitis(gr 3/4 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Kidney infection(gr 0/1/2 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Kidney infection(gr 3/4 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Laryngitis(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Nail infection(gr 0/1/2 ANC)	0/615 (0%)	0	1/647 (0.2%)	3	0/646 (0%)	0	0/618 (0%)	0
Otitis media(gr 3/4 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Peripheral nerve infection(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Pneumonia(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Pneumonia(gr 3/4 ANC)	2/615 (0.3%)	2	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Pneumonia(unknown ANC)	3/615 (0.5%)	3	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Rhinitis infective(gr 3/4 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Salivary gland infection(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Scrotal infection(unknown ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	2	0/618 (0%)	0
Sepsis(gr 0/1/2 ANC)	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Sepsis(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Sinusitis(gr 0/1/2 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Sinusitis(gr 3/4 ANC)	1/615 (0.2%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Skin infection	1/615 (0.2%)	1	4/647 (0.6%)	4	4/646 (0.6%)	5	3/618 (0.5%)	7
Skin infection(gr 3/4 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	2/646 (0.3%)	2	3/618 (0.5%)	3
Skin infection(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Soft tissue infection(gr 0/1/2 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Soft tissue infection(gr 3/4 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Tooth infection	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	3/618 (0.5%)	3
Tooth infection(gr 3/4 ANC)	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Upper respiratory infection(gr 3/4 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	2/618 (0.3%)	2
Upper respiratory infection(unknown ANC)	0/615 (0%)	0	1/647 (0.2%)	1	2/646 (0.3%)	3	1/618 (0.2%)	1
Upper respiratory infectn(gr 0/1/2 ANC)	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Urinary tract infection(gr 0/1/2 ANC)	4/615 (0.7%)	4	3/647 (0.5%)	3	1/646 (0.2%)	1	4/618 (0.6%)	4
Urinary tract infection(gr 3/4 ANC)	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Urinary tract infection(unknown ANC)	0/615 (0%)	0	2/647 (0.3%)	2	1/646 (0.2%)	2	3/618 (0.5%)	3
Vaginal infection(gr 0/1/2 ANC)	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Viral hepatitis	1/615 (0.2%)	1	1/647 (0.2%)	3	0/646 (0%)	0	0/618 (0%)	0
Wound infection	0/615 (0%)	0	4/647 (0.6%)	5	2/646 (0.3%)	3	0/618 (0%)	0
Wound infection(gr 0/1/2 ANC)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Wound infection(gr 3/4 ANC)	1/615 (0.2%)	2	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Injury, poisoning and procedural complications
Arterial injury - Extremity-lower	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Bruising	1/615 (0.2%)	1	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Fracture	4/615 (0.7%)	5	6/647 (0.9%)	6	3/646 (0.5%)	3	1/618 (0.2%)	1
Injury to carotid artery	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Intraop. inj. - Colon	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Intraop. inj. - Joint	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	2
Intraop. inj. - Small bowel NOS	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Intraop. inj. - Vein-major visceral vein	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Intraoperative complications	0/615 (0%)	0	2/647 (0.3%)	3	0/646 (0%)	0	0/618 (0%)	0
Intraoperative gastrointestinal injury	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	5
Intraoperative ocular injury	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	2
Intraoperative urinary injury - Bladder	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Large intestinal anastomotic leak	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Postoperative hemorrhage	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Rectal anastomotic leak	0/615 (0%)	0	1/647 (0.2%)	2	0/646 (0%)	0	0/618 (0%)	0
Vascular access complication	4/615 (0.7%)	16	5/647 (0.8%)	5	9/646 (1.4%)	19	5/618 (0.8%)	10
Venous injury - Extremity-lower	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Wound dehiscence	2/615 (0.3%)	2	1/647 (0.2%)	7	0/646 (0%)	0	3/618 (0.5%)	3
Investigations
Activated partial throm time prolonged	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	2
Alanine aminotransferase increased	8/615 (1.3%)	17	10/647 (1.5%)	29	8/646 (1.2%)	12	10/618 (1.6%)	28
Alkaline phosphatase increased	8/615 (1.3%)	15	11/647 (1.7%)	19	1/646 (0.2%)	1	5/618 (0.8%)	10
Amylase increased	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Aspartate aminotransferase increased	16/615 (2.6%)	35	14/647 (2.2%)	39	8/646 (1.2%)	9	13/618 (2.1%)	28
Blood bilirubin increased	4/615 (0.7%)	9	4/647 (0.6%)	6	3/646 (0.5%)	4	4/618 (0.6%)	15
CD4 lymphocytes decreased	0/615 (0%)	0	1/647 (0.2%)	2	0/646 (0%)	0	1/618 (0.2%)	1
Creatinine increased	76/615 (12.4%)	256	126/647 (19.5%)	418	85/646 (13.2%)	316	100/618 (16.2%)	306
Gamma-glutamyltransferase increased	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	9	0/618 (0%)	0
INR increased	3/615 (0.5%)	7	8/647 (1.2%)	21	5/646 (0.8%)	10	0/618 (0%)	0
Laboratory test abnormal	4/615 (0.7%)	8	2/647 (0.3%)	3	0/646 (0%)	0	3/618 (0.5%)	4
Leukocyte count decreased	23/615 (3.7%)	49	27/647 (4.2%)	43	15/646 (2.3%)	18	18/618 (2.9%)	28
Lipase increased	0/615 (0%)	0	1/647 (0.2%)	7	2/646 (0.3%)	4	0/618 (0%)	0
Lymphocyte count decreased	2/615 (0.3%)	3	6/647 (0.9%)	7	4/646 (0.6%)	4	4/618 (0.6%)	10
Neutrophil count decreased	385/615 (62.6%)	987	400/647 (61.8%)	981	303/646 (46.9%)	564	312/618 (50.5%)	583
Platelet count decreased	373/615 (60.7%)	1552	417/647 (64.5%)	1827	332/646 (51.4%)	828	315/618 (51%)	881
Weight gain	10/615 (1.6%)	19	12/647 (1.9%)	33	10/646 (1.5%)	19	8/618 (1.3%)	26
Weight loss	9/615 (1.5%)	10	4/647 (0.6%)	5	2/646 (0.3%)	3	4/618 (0.6%)	8
Metabolism and nutrition disorders
Acidosis	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	2	1/618 (0.2%)	1
Alkalosis	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Anorexia	15/615 (2.4%)	28	17/647 (2.6%)	19	8/646 (1.2%)	9	7/618 (1.1%)	18
Blood bicarbonate decreased	0/615 (0%)	0	1/647 (0.2%)	2	0/646 (0%)	0	1/618 (0.2%)	1
Blood glucose increased	31/615 (5%)	74	47/647 (7.3%)	100	37/646 (5.7%)	84	26/618 (4.2%)	55
Blood uric acid increased	0/615 (0%)	0	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Dehydration	4/615 (0.7%)	4	17/647 (2.6%)	24	9/646 (1.4%)	9	6/618 (1%)	6
Glucose intolerance	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Obesity	1/615 (0.2%)	4	2/647 (0.3%)	12	3/646 (0.5%)	5	3/618 (0.5%)	11
Serum albumin decreased	4/615 (0.7%)	9	7/647 (1.1%)	14	5/646 (0.8%)	5	9/618 (1.5%)	15
Serum calcium decreased	2/615 (0.3%)	2	3/647 (0.5%)	10	6/646 (0.9%)	10	5/618 (0.8%)	6
Serum calcium increased	3/615 (0.5%)	5	4/647 (0.6%)	5	4/646 (0.6%)	6	0/618 (0%)	0
Serum glucose decreased	1/615 (0.2%)	1	3/647 (0.5%)	3	4/646 (0.6%)	4	2/618 (0.3%)	2
Serum magnesium decreased	1/615 (0.2%)	1	2/647 (0.3%)	3	1/646 (0.2%)	1	1/618 (0.2%)	1
Serum phosphate decreased	4/615 (0.7%)	8	3/647 (0.5%)	5	4/646 (0.6%)	8	3/618 (0.5%)	3
Serum potassium decreased	28/615 (4.6%)	39	26/647 (4%)	33	23/646 (3.6%)	28	11/618 (1.8%)	12
Serum potassium increased	2/615 (0.3%)	2	3/647 (0.5%)	4	4/646 (0.6%)	4	2/618 (0.3%)	2
Serum sodium decreased	8/615 (1.3%)	20	6/647 (0.9%)	14	8/646 (1.2%)	17	5/618 (0.8%)	7
Serum sodium increased	2/615 (0.3%)	2	2/647 (0.3%)	2	1/646 (0.2%)	1	0/618 (0%)	0
Serum triglycerides increased	2/615 (0.3%)	2	1/647 (0.2%)	5	2/646 (0.3%)	3	0/618 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	5/615 (0.8%)	17	6/647 (0.9%)	11	11/646 (1.7%)	22	5/618 (0.8%)	8
Arthritis	3/615 (0.5%)	5	2/647 (0.3%)	3	1/646 (0.2%)	1	3/618 (0.5%)	9
Back pain	14/615 (2.3%)	32	12/647 (1.9%)	36	11/646 (1.7%)	15	12/618 (1.9%)	31
Bone pain	2/615 (0.3%)	4	4/647 (0.6%)	7	2/646 (0.3%)	2	2/618 (0.3%)	3
Chest wall pain	2/615 (0.3%)	2	1/647 (0.2%)	1	2/646 (0.3%)	2	0/618 (0%)	0
Joint effusion	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Joint range motion decr cervical spine	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Muscle weakness	5/615 (0.8%)	6	9/647 (1.4%)	9	1/646 (0.2%)	2	4/618 (0.6%)	4
Muscle weakness lower limb	1/615 (0.2%)	1	2/647 (0.3%)	2	0/646 (0%)	0	4/618 (0.6%)	4
Muscle weakness right-sided	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Muscle weakness upper limb	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	2
Musculoskeletal disorder	4/615 (0.7%)	6	5/647 (0.8%)	11	5/646 (0.8%)	7	5/618 (0.8%)	24
Myalgia	6/615 (1%)	19	4/647 (0.6%)	11	4/646 (0.6%)	18	6/618 (1%)	7
Neck pain	4/615 (0.7%)	9	2/647 (0.3%)	2	2/646 (0.3%)	7	1/618 (0.2%)	1
Osteoporosis	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Pain in extremity	13/615 (2.1%)	31	9/647 (1.4%)	11	7/646 (1.1%)	7	6/618 (1%)	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy	3/615 (0.5%)	3	3/647 (0.5%)	3	2/646 (0.3%)	2	0/618 (0%)	0
Nervous system disorders
Accessory nerve disorder	1/615 (0.2%)	3	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	6
Ataxia	3/615 (0.5%)	4	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Cognitive disturbance	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Dizziness	6/615 (1%)	11	10/647 (1.5%)	12	7/646 (1.1%)	7	5/618 (0.8%)	11
Dysgeusia	6/615 (1%)	11	10/647 (1.5%)	14	5/646 (0.8%)	10	5/618 (0.8%)	8
Extrapyramidal disorder	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Facial nerve disorder	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Headache	14/615 (2.3%)	25	12/647 (1.9%)	18	8/646 (1.2%)	14	14/618 (2.3%)	26
Hydrocephalus	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Intracranial hemorrhage	0/615 (0%)	0	0/647 (0%)	0	2/646 (0.3%)	2	0/618 (0%)	0
Ischemia cerebrovascular	7/615 (1.1%)	12	7/647 (1.1%)	7	6/646 (0.9%)	6	2/618 (0.3%)	2
Memory impairment	3/615 (0.5%)	5	2/647 (0.3%)	4	0/646 (0%)	0	0/618 (0%)	0
Neuralgia	1/615 (0.2%)	1	2/647 (0.3%)	4	0/646 (0%)	0	0/618 (0%)	0
Neurological disorder NOS	4/615 (0.7%)	11	2/647 (0.3%)	5	2/646 (0.3%)	2	0/618 (0%)	0
Olfactory nerve disorder	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Peripheral motor neuropathy	1/615 (0.2%)	1	3/647 (0.5%)	6	3/646 (0.5%)	4	0/618 (0%)	0
Peripheral sensory neuropathy	516/615 (83.9%)	4338	556/647 (85.9%)	4460	501/646 (77.6%)	2756	485/618 (78.5%)	2662
Seizure	3/615 (0.5%)	4	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Speech disorder	0/615 (0%)	0	1/647 (0.2%)	5	1/646 (0.2%)	1	0/618 (0%)	0
Syncope	9/615 (1.5%)	9	9/647 (1.4%)	10	3/646 (0.5%)	3	9/618 (1.5%)	9
Syncope vasovagal	2/615 (0.3%)	2	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Tremor	2/615 (0.3%)	3	2/647 (0.3%)	3	0/646 (0%)	0	1/618 (0.2%)	1
Psychiatric disorders
Agitation	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Anxiety	6/615 (1%)	14	10/647 (1.5%)	17	10/646 (1.5%)	18	13/618 (2.1%)	20
Confusion	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Depression	5/615 (0.8%)	16	5/647 (0.8%)	8	7/646 (1.1%)	18	7/618 (1.1%)	10
Insomnia	8/615 (1.3%)	24	10/647 (1.5%)	19	7/646 (1.1%)	24	12/618 (1.9%)	29
Irritability	0/615 (0%)	0	1/647 (0.2%)	4	0/646 (0%)	0	0/618 (0%)	0
Personality change	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Psychosis	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Renal and urinary disorders
Bladder hemorrhage	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Bladder obstruction	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Cystitis	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	1/618 (0.2%)	1
Glomerular filtration rate decreased	1/615 (0.2%)	1	2/647 (0.3%)	2	1/646 (0.2%)	2	1/618 (0.2%)	1
Hemoglobin urine positive	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Hemorrhage urinary tract	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Kidney pain	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Proteinuria	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Renal failure	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	2/618 (0.3%)	2
Ureteric obstruction	0/615 (0%)	0	0/647 (0%)	0	3/646 (0.5%)	3	0/618 (0%)	0
Urinary frequency	2/615 (0.3%)	3	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Urinary incontinence	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	3/618 (0.5%)	4
Urinary retention	1/615 (0.2%)	2	1/647 (0.2%)	1	1/646 (0.2%)	1	0/618 (0%)	0
Urogenital disorder	1/615 (0.2%)	1	5/647 (0.8%)	5	8/646 (1.2%)	9	2/618 (0.3%)	3
Reproductive system and breast disorders
Breast pain	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	2
Erectile dysfunction	0/615 (0%)	0	1/647 (0.2%)	1	2/646 (0.3%)	3	0/618 (0%)	0
Irregular menstruation	0/615 (0%)	0	1/647 (0.2%)	4	0/646 (0%)	0	1/618 (0.2%)	1
Nipple deformity	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Scrotal pain	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Vaginal discharge	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	1/618 (0.2%)	1
Vaginal hemorrhage	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Vaginal inflammation	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Vaginal pain	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	5/615 (0.8%)	5	1/647 (0.2%)	2	0/646 (0%)	0	5/618 (0.8%)	13
Apnea	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	2/618 (0.3%)	2
Aspiration	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Atelectasis	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	3
Cough	7/615 (1.1%)	7	4/647 (0.6%)	4	5/646 (0.8%)	5	10/618 (1.6%)	18
Dyspnea	10/615 (1.6%)	13	10/647 (1.5%)	12	8/646 (1.2%)	19	8/618 (1.3%)	14
Epistaxis	2/615 (0.3%)	2	5/647 (0.8%)	6	2/646 (0.3%)	3	6/618 (1%)	11
Hiccups	0/615 (0%)	0	4/647 (0.6%)	5	2/646 (0.3%)	4	0/618 (0%)	0
Hypoxia	3/615 (0.5%)	3	1/647 (0.2%)	2	2/646 (0.3%)	2	1/618 (0.2%)	1
Laryngeal fistula	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Laryngeal pain	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Nasal congestion	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Pharyngeal mucositis (clin exam)	0/615 (0%)	0	3/647 (0.5%)	3	3/646 (0.5%)	4	0/618 (0%)	0
Pharyngeal mucositis (funct/sympt)	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Pharyngolaryngeal pain	0/615 (0%)	0	2/647 (0.3%)	2	0/646 (0%)	0	0/618 (0%)	0
Pleural effusion	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Pleuritic pain	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Pneumonitis	0/615 (0%)	0	0/647 (0%)	0	2/646 (0.3%)	2	5/618 (0.8%)	7
Pneumothorax	1/615 (0.2%)	1	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Pulmonary fibrosis	1/615 (0.2%)	1	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Respiratory disorder	2/615 (0.3%)	5	7/647 (1.1%)	8	3/646 (0.5%)	3	2/618 (0.3%)	2
Respiratory tract hemorrhage	0/615 (0%)	0	0/647 (0%)	0	0/646 (0%)	0	1/618 (0.2%)	1
Voice alteration	1/615 (0.2%)	1	1/647 (0.2%)	1	1/646 (0.2%)	1	1/618 (0.2%)	1
Skin and subcutaneous tissue disorders
Alopecia	6/615 (1%)	14	9/647 (1.4%)	15	6/646 (0.9%)	8	10/618 (1.6%)	17
Dry skin	2/615 (0.3%)	2	2/647 (0.3%)	4	2/646 (0.3%)	5	4/618 (0.6%)	10
Erythema multiforme	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Hand-and-foot syndrome/reaction	8/615 (1.3%)	13	7/647 (1.1%)	10	3/646 (0.5%)	6	5/618 (0.8%)	6
Nail disorder	1/615 (0.2%)	4	2/647 (0.3%)	3	0/646 (0%)	0	3/618 (0.5%)	4
Pain of skin	1/615 (0.2%)	1	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Pruritus	5/615 (0.8%)	6	6/647 (0.9%)	11	2/646 (0.3%)	2	6/618 (1%)	11
Rash acneiform	1/615 (0.2%)	2	8/647 (1.2%)	13	1/646 (0.2%)	1	3/618 (0.5%)	5
Rash desquamating	5/615 (0.8%)	5	4/647 (0.6%)	6	4/646 (0.6%)	8	3/618 (0.5%)	3
Skin disorder	6/615 (1%)	6	4/647 (0.6%)	4	5/646 (0.8%)	16	6/618 (1%)	8
Skin hyperpigmentation	3/615 (0.5%)	5	4/647 (0.6%)	9	0/646 (0%)	0	3/618 (0.5%)	3
Skin hypopigmentation	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Skin ulceration	1/615 (0.2%)	1	0/647 (0%)	0	3/646 (0.5%)	3	1/618 (0.2%)	1
Sweating	1/615 (0.2%)	2	0/647 (0%)	0	1/646 (0.2%)	13	1/618 (0.2%)	8
Urticaria	1/615 (0.2%)	1	2/647 (0.3%)	3	2/646 (0.3%)	2	4/618 (0.6%)	4
Vascular disorders
Flushing	0/615 (0%)	0	1/647 (0.2%)	1	0/646 (0%)	0	0/618 (0%)	0
Hematoma	2/615 (0.3%)	3	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0
Hemorrhage	2/615 (0.3%)	2	0/647 (0%)	0	2/646 (0.3%)	5	1/618 (0.2%)	1
Hot flashes	2/615 (0.3%)	3	5/647 (0.8%)	16	0/646 (0%)	0	3/618 (0.5%)	4
Hypertension	216/615 (35.1%)	1147	264/647 (40.8%)	1474	250/646 (38.7%)	1159	252/618 (40.8%)	1385
Hypotension	4/615 (0.7%)	6	4/647 (0.6%)	6	1/646 (0.2%)	1	3/618 (0.5%)	3
Peripheral ischemia	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	3	0/618 (0%)	0
Phlebitis	2/615 (0.3%)	2	0/647 (0%)	0	0/646 (0%)	0	0/618 (0%)	0
Thrombosis	6/615 (1%)	8	17/647 (2.6%)	38	16/646 (2.5%)	24	11/618 (1.8%)	28
Vascular disorder	0/615 (0%)	0	0/647 (0%)	0	1/646 (0.2%)	1	0/618 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Jeffrey A. Meyerhardt, MD, MPH
Organization	Alliance for Clinical Trials in Oncology
Phone	617-632-6855
Email	jmeyerhardt@partners.org

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT01150045

Other Study ID Numbers:

CALGB-80702
U10CA031946
CALGB-80702
CDR0000675693

First Posted:

Jun 24, 2010

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

Study Details

Study Description

Brief Summary

Detailed Description

Primary objective:

Secondary objectives:

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

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Publications

Study Results

Participant Flow

Baseline Characteristics

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Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

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Results Point of Contact