Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00052910

Collaborator

National Cancer Institute (NCI) (NIH)

546

Enrollment

535

Locations

Arms

168

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Drug: cisplatin Drug: epirubicin hydrochloride Drug: fluorouracil Drug: leucovorin calcium Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

Compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin, and infusional fluorouracil (5-FU) vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy.
Compare disease-free survival and local and distant recurrence rates in these patients treated with these regimens.
Correlate the expression of putative prognostic markers (including TS, ERCC-1, MSI, E-cadherin, EGFR, p27, COX-2, and c-erbB-2) with overall survival of patients treated with these regimens.
Correlate specific germline polymorphisms related to chemotherapy metabolism and resistance (including UGT2B7 [epirubicin], GST [cisplatin], ERCCI [cisplatin], XRCC1 [cisplatin], TS [5-FU], DPD [5-FU], and EGFR polymorphisms) with treatment-related toxicity and overall survival of these patients.
Correlate serum levels of insulin-like growth factor-1 (IGF-1), IGF-2, and IGF-binding protein 3 with overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days between course 2 and 3.
Arm II: Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 824 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

546 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma

Study Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.	Drug: fluorouracil Given IV Drug: leucovorin calcium Given IV Radiation: radiation therapy Given 5 days a week for 5 weeks
Experimental: Arm II Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.	Drug: cisplatin Given IV Drug: epirubicin hydrochloride Given IV Drug: fluorouracil Given IV Radiation: radiation therapy Given 5 days a week for 5 weeks

Arm

Intervention/Treatment

Active Comparator: Arm I

Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.

Drug: fluorouracil

Given IV

Drug: leucovorin calcium

Given IV

Radiation: radiation therapy

Given 5 days a week for 5 weeks

Experimental: Arm II

Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

Drug: cisplatin

Given IV

Drug: epirubicin hydrochloride

Given IV

Drug: fluorouracil

Given IV

Radiation: radiation therapy

Given 5 days a week for 5 weeks

Outcome Measures

Primary Outcome Measures

Overall Survival [From study enrollment until death from any cause; up to 3 years]
Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Secondary Outcome Measures

Disease Free Survival [From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years]
Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Required Tumor Parameters

1.1 Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.

1.2 Patients must have had en bloc resection of all known tumor. The surgical resection must have been done with a curative intent.

1.3 Patients must have tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease.

Patients can have stages IB if there is evidence of either node-positive (N1) disease or tumor extension beyond the muscularis propria (i.e., T1, N1, M0 patients are eligible but patients with T2, N0, M0 are allowed only if there is extension beyond the muscularis propria).
Patients can have stages II, IIIA, IIIB or stage IV with M0 (i.e., T4N2M0).
Stages 0, IA, or any stage with M1 are not allowed. (see Appendix I for TNM staging guide).

1.4 Patients with known unresected cancer, recurrent cancer, microscopic evidence of tumor at the distal or proximal line of stomach resection, noncontiguous resection of tumor, or M1 (metastatic) disease are ineligible.

Prior Therapy

2.1 No prior therapy (except hormonal or biologic) for other malignancies is allowed except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years.

2.2 Patients who have had any previous chemotherapy or radiotherapy are ineligible.

Patient Characteristics

3.1 Patients must have an ECOG (CTC) performance status of 0, 1 or 2.

3.2 Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical body weight. Patients must have documentation of stable weight (or less than 2 pounds weight loss) for at least one week prior to registration.

3.3 All patients must be evaluated by a radiation oncologist (prior to enrollment) to ensure that the patient is an appropriate candidate for radiation therapy.

3.4 Patients may not have unilateral renal function (only one functioning kidney) as determined by CT scan with contrast, urogram, renal scan, or other study.

3.5 Pregnant or lactating women may not participate. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method or practice abstinence while in this study.

The effects of therapeutic radiotherapy are known to be teratogenic.
The effects of Epirubicin, Cisplatin, and 5-FU on a developing human fetus at the recommended therapeutic dose are less well known.
For this reason and because DNA alkylating agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
Should a woman become pregnant or suspect she is pregnant while participating on this study, she should inform her treating physician immediately. Because the risk of toxicity in nursing infants secondary to Epirubicin, Cisplatin, and 5-FU treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued.

3.6 Patients with any of the following cardiac conditions are ineligible:

Uncontrolled high blood pressure
Unstable angina
Symptomatic congestive heart failure
Myocardial infarction < 6 months prior to registration
Serious uncontrolled cardiac arrhythmia
New York Heart Association classification III or IV.

3.7 No uncontrolled serious medical or psychiatric illness which would prevent compliance with treatment or adequate informed consent.

3.8 Patients with active infectious process are ineligible.

3.9 Patients with grade 2 or greater peripheral neuropathy at baseline are ineligible.

Required Initial Laboratory Values:

Granulocytes ≥ 1,500/μl
Platelet count ≥ 100,000/μl
Creatinine ≤ 1.5 mg/dl
Bilirubin ≤ 2.0 mg/dl
AST ≤ 3x upper limits of normal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Medical Center	Anniston	Alabama	United States	36202
2	Providence Cancer Center at Providence Hospital	Mobile	Alabama	United States	36608
3	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
4	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724-5024
5	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Fort Smith	Arkansas	United States	72903
6	Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center	Jonesboro	Arkansas	United States	72401-9320
7	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
8	Kaiser Permanente - Deer Valley	Antioch	California	United States	94531
9	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
10	East Bay Radiation Oncology Center	Castro Valley	California	United States	94546
11	Eden Medical Center	Castro Valley	California	United States	94546
12	Valley Medical Oncology Consultants - Castro Valley	Castro Valley	California	United States	94546
13	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
14	Kaiser Permanente - Fremont	Fremont	California	United States	94538
15	Valley Medical Oncology	Fremont	California	United States	94538
16	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California	United States	91204
17	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
18	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
19	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
20	Memorial Medical Center	Modesto	California	United States	95355
21	Community Hospital of the Monterey Peninsula Comprehensive Cancer Center	Monterey	California	United States	93940
22	Camino Medical Group - Treatment Center	Mountain View	California	United States	94040
23	El Camino Hospital Cancer Center	Mountain View	California	United States	94040
24	Highland General Hospital	Oakland	California	United States	94602
25	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
26	Bay Area Breast Surgeons, Incorporated	Oakland	California	United States	94609
27	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
28	Larry G Strieff MD Medical Corporation	Oakland	California	United States	94609
29	Tom K Lee, Incorporated	Oakland	California	United States	94609
30	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
31	Valley Care Medical Center	Pleasanton	California	United States	94588
32	Valley Medical Oncology Consultants - Pleasanton	Pleasanton	California	United States	94588
33	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
34	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
35	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
36	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
37	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
38	San Francisco General Hospital Medical Center	San Francisco	California	United States	94110
39	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
40	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
41	Doctors Medical Center - San Pablo Campus	San Pablo	California	United States	94806
42	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
43	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
44	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
45	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
46	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
47	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
48	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
49	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
50	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
51	Memorial Hospital Cancer Center - Colorado Springs	Colorado Springs	Colorado	United States	80909
52	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
53	St. Anthony Central Hospital	Denver	Colorado	United States	80204
54	Porter Adventist Hospital	Denver	Colorado	United States	80210
55	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
56	St. Joseph Hospital	Denver	Colorado	United States	80218
57	Rose Medical Center	Denver	Colorado	United States	80220
58	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80224-2522
59	Swedish Medical Center	Englewood	Colorado	United States	80110
60	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
61	North Colorado Medical Center	Greeley	Colorado	United States	80631
62	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
63	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
64	McKee Medical Center	Loveland	Colorado	United States	80539
65	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
66	North Suburban Medical Center	Thornton	Colorado	United States	80229
67	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
68	Praxair Cancer Center at Danbury Hospital	Danbury	Connecticut	United States	06810
69	Helen and Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut	United States	06102-5037
70	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
71	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
72	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
73	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
74	Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus	Boca Raton	Florida	United States	33486
75	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
76	Broward General Medical Center Cancer Center	Fort Lauderdale	Florida	United States	33316
77	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida	United States	33021
78	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida	United States	32207
79	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida	United States	33458
80	Center for Cancer Care and Research at Watson Clinic, LLP	Lakeland	Florida	United States	33805
81	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
82	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida	United States	32504
83	West Florida Cancer Institute at West Florida Hospital - Pensacola	Pensacola	Florida	United States	32514
84	Cleveland Clinic Florida - Weston	Weston	Florida	United States	33331
85	Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31701
86	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
87	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
88	Medical Center of Central Georgia	Macon	Georgia	United States	31208
89	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
90	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia	United States	31405
91	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712
92	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
93	Hematology Oncology Associates of Illinois - Berwyn	Berwyn	Illinois	United States	60402
94	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
95	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
96	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
97	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois	United States	60612
98	Resurrection Medical Center	Chicago	Illinois	United States	60631
99	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
100	Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Chicago	Illinois	United States	60657
101	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
102	St. Anthony's Memorial Hospital	Effingham	Illinois	United States	62401
103	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
104	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
105	Veterans Affairs Medical Center - Hines	Hines	Illinois	United States	60141
106	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
107	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
108	La Grange Memorial Hospital	La Grange	Illinois	United States	60525
109	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
110	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
111	Edward Hospital Cancer Center	Naperville	Illinois	United States	60540
112	Hematology Oncology Consultants - Naperville	Naperville	Illinois	United States	60540
113	La Grange Oncology Associates - Geneva	Naperville	Illinois	United States	60563
114	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois	United States	60714
115	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453-2699
116	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois	United States	60461
117	West Suburban Center for Cancer Care	River Forest	Illinois	United States	60305
118	Swedish-American Regional Cancer Center	Rockford	Illinois	United States	61104-2315
119	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
120	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
121	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
122	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
123	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
124	Elkhart General Hospital	Elkhart	Indiana	United States	46515
125	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46845
126	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
127	William N. Wishard Memorial Hospital	Indianapolis	Indiana	United States	46202
128	Howard Community Hospital	Kokomo	Indiana	United States	46904
129	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
130	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
131	Cancer Center at Ball Memorial Hospital	Muncie	Indiana	United States	47303-3499
132	Medical Consultants, PC at Ball Memorial Cancer Center	Muncie	Indiana	United States	47303
133	Community Hospital	Munster	Indiana	United States	46321
134	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
135	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
136	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
137	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
138	South Bend Clinic	South Bend	Indiana	United States	46617
139	McFarland Clinic, PC	Ames	Iowa	United States	50010
140	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
141	Iowa Blood and Cancer Care	Cedar Rapids	Iowa	United States	52402
142	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
143	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
144	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
145	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
146	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
147	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
148	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
149	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
150	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
151	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
152	McCreery Cancer Center at Ottumwa Regional	Ottumwa	Iowa	United States	52501
153	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
154	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
155	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
156	Cedar Valley Medical Specialists, PC - West Ridgeway Avenue	Waterloo	Iowa	United States	50701
157	Covenant Cancer Treatment Center	Waterloo	Iowa	United States	50702
158	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
159	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
160	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
161	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
162	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
163	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
164	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
165	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
166	Southwest Medical Center	Liberal	Kansas	United States	67901
167	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
168	Menorah Medical Center	Overland Park	Kansas	United States	66209
169	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
170	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
171	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
172	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
173	Shawnee Mission Medical Center	Shawnee Mission	Kansas	United States	66204
174	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
175	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
176	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
177	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
178	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
179	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
180	CCOP - Wichita	Wichita	Kansas	United States	67214
181	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
182	Wesley Medical Center	Wichita	Kansas	United States	67214
183	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
184	Pennington Cancer Center at Baton Rouge General	Baton Rouge	Louisiana	United States	70806
185	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
186	Ochsner Health Center - Bluebonnet	Baton Rouge	Louisiana	United States	70809
187	Ochsner Health Center - Covington	Covington	Louisiana	United States	70433
188	Terrebonne General Medical Center	Houma	Louisiana	United States	70360
189	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
190	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
191	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
192	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
193	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
194	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
195	Shore Regional Cancer Center at Memorial Hospital - Easton	Easton	Maryland	United States	21601
196	Union Hospital Cancer Program at Union Hospital	Elkton	Maryland	United States	21921
197	Associates in Oncology and Hematology	Kensington	Maryland	United States	20895
198	Associates in Oncology and Hematology - Medical Center Drive	Rockville	Maryland	United States	20878
199	Tufts-NEMC Cancer Center	Boston	Massachusetts	United States	02111
200	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
201	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts	United States	02115
202	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
203	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
204	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
205	Caritas St. Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135-2997
206	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts	United States	01805
207	Hudner Oncology Center at Saint Anne's Hospital - Fall River	Fall River	Massachusetts	United States	02721
208	Addison Gilbert Hospital	Gloucester	Massachusetts	United States	01930
209	Cape Cod Hospital	Hyannis	Massachusetts	United States	02601
210	Lowell General Hospital	Lowell	Massachusetts	United States	01854
211	Berkshire Hematology Oncology, PC	Pittsfield	Massachusetts	United States	01201
212	South Shore Hospital	South Weymouth	Massachusetts	United States	02190
213	Morton Hospital & Medical Center	Taunton	Massachusetts	United States	02780
214	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
215	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
216	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
217	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
218	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
219	Bay Regional Medical Center	Bay City	Michigan	United States	48708
220	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
221	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
222	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
223	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
224	Hurley Medical Center	Flint	Michigan	United States	48503
225	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
226	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
227	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
228	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
229	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
230	Foote Memorial Hospital	Jackson	Michigan	United States	49201
231	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
232	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
233	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
234	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
235	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
236	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
237	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
238	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
239	Mercy General Health Partners	Muskegon	Michigan	United States	49443
240	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
241	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
242	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
243	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
244	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
245	Oncology Care Associates, PLLC	Saint Joseph	Michigan	United States	49085
246	Munson Medical Center	Traverse City	Michigan	United States	49684
247	St. John Macomb Hospital	Warren	Michigan	United States	48093
248	Metro Health Hospital	Wyoming	Michigan	United States	49519
249		Alexandria	Minnesota	United States	56308
250	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
251	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
252	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
253	CCOP - Duluth	Duluth	Minnesota	United States	55805
254	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
255	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
256		Fergus Falls	Minnesota	United States	56537
257	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
258	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
259	Meeker County Memorial Hospital	Litchfield	Minnesota	United States	55355
260	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
261	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota	United States	55109
262	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
263	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
264	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
265	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota	United States	55422-2900
266	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
267	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
268	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
269	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
270	Park Nicollet Cancer Center	Saint Louis Park	Minnesota	United States	55416
271	Regions Hospital Cancer Care Center	Saint Paul	Minnesota	United States	55101
272	HealthEast Cancer Care at St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102
273	United Hospital	Saint Paul	Minnesota	United States	55102
274	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
275	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
276	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota	United States	56201
277	HealthEast Cancer Care at Woodwinds Health Campus	Woodbury	Minnesota	United States	55125
278	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota	United States	55125
279	Hattiesburg Clinic, PA at Forrest General	Hattiesburg	Mississippi	United States	39401
280	Hematology & Oncology Clinic	Hattiesburg	Mississippi	United States	39402
281	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
282	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
283	Independence Regional Health Center	Independence	Missouri	United States	64050
284	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
285	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
286	St. Joseph Medical Center	Kansas City	Missouri	United States	64114
287	North Kansas City Hospital	Kansas City	Missouri	United States	64116
288	Parvin Radiation Oncology	Kansas City	Missouri	United States	64116
289	CCOP - Kansas City	Kansas City	Missouri	United States	64131
290	Research Medical Center	Kansas City	Missouri	United States	64132
291	Liberty Hospital	Liberty	Missouri	United States	64068
292	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
293	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
294	Christian Hospital Northeast Cancer Care Center	Saint Louis	Missouri	United States	63136
295	Arch Medical Services, Incorporated at Center for Cancer Care and Research	Saint Louis	Missouri	United States	63141
296	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
297	St. John's Regional Health Center	Springfield	Missouri	United States	65804
298	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
299	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
300	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
301	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
302	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
303	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
304	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
305	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
306	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
307	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
308		Great Falls	Montana	United States	59405
309	Northern Montana Hospital	Havre	Montana	United States	59501
310	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
311	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
312	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
313	Community Medical Center	Missoula	Montana	United States	59801
314	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
315	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
316	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
317	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska	United States	68848-1990
318	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
319	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
320	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
321	Immanuel Medical Center	Omaha	Nebraska	United States	68122
322	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
323	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
324	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
325	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
326	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire	United States	03103
327	John F. Kennedy Medical Center	Edison	New Jersey	United States	08818
328	CentraState Medical Center	Freehold	New Jersey	United States	07728
329	St. Barnabas Medical Center Cancer Center	Livingston	New Jersey	United States	07039
330	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey	United States	08053
331	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
332	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
333	Overlook Hospital	Summit	New Jersey	United States	07902
334	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Vineland	New Jersey	United States	08360
335	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
336	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey	United States	08043
337	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York	United States	10466
338	Kings County Hospital Center	Brooklyn	New York	United States	11203
339	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
340	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
341	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
342	Ralph Lauren Center for Cancer Care and Prevention	New York	New York	United States	10035
343	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
344	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
345	Nalitt Cancer Institute at Staten Island University Hospital	Staten Island	New York	United States	10305
346	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
347	Mission Hospitals - Memorial Campus	Asheville	North Carolina	United States	28801
348	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
349	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
350	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
351	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
352	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina	United States	27834
353	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
354	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina	United States	28374
355	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
356	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
357	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
358	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
359	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
360	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
361	Dakota Cancer Institute at Dakota Clinic - South University	Fargo	North Dakota	United States	58103
362	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota	United States	58201
363	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
364	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio	United States	44309-2090
365	Mary Rutan Hospital	Bellefontaine	Ohio	United States	43311
366	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
367	Aultman Cancer Center at Aultman Hospital	Canton	Ohio	United States	44710-1799
368	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
369	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
370	North Coast Cancer Care - Clyde	Clyde	Ohio	United States	43410
371	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210-1240
372	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
373	CCOP - Columbus	Columbus	Ohio	United States	43215
374	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
375	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
376	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
377	Grandview Hospital	Dayton	Ohio	United States	45405
378	Good Samaritan Hospital	Dayton	Ohio	United States	45406
379	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
380	CCOP - Dayton	Dayton	Ohio	United States	45429
381	Grady Memorial Hospital	Delaware	Ohio	United States	43015
382	Hematology Oncology Center	Elyria	Ohio	United States	44035
383	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
384	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
385	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
386	Fairfield Medical Center	Lancaster	Ohio	United States	43130
387	St. Rita's Medical Center	Lima	Ohio	United States	45801
388	Lima Memorial Hospital	Lima	Ohio	United States	45804
389	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
390	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
391	St. Luke's Hospital	Maumee	Ohio	United States	43537
392	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
393	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
394	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
395	Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford	Salem	Ohio	United States	44460
396	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
397	Mercy Medical Center	Springfield	Ohio	United States	45504
398	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
399	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
400	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
401	Toledo Hospital	Toledo	Ohio	United States	43606
402	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
403	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
404	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
405	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
406	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
407	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
408	Fulton County Health Center	Wauseon	Ohio	United States	43567
409	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
410	Clinton Memorial Hospital	Wilmington	Ohio	United States	45177
411	Cancer Treatment Center	Wooster	Ohio	United States	44691
412	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
413	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
414	Cleo Craig Cancer Research Clinic	Lawton	Oklahoma	United States	73505
415	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
416	Cancer Care Associates - Mercy Campus	Oklahoma City	Oklahoma	United States	73120
417	Kaiser Permanente Health Care - Portland	Portland	Oregon	United States	97232
418	Salem Hospital Regional Cancer Care Services	Salem	Oregon	United States	97309-5014
419	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
420	UPMC Cancer Center at Beaver Medical Center	Beaver	Pennsylvania	United States	15009
421	St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	Pennsylvania	United States	18015
422	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
423	UPMC Cancer Center at Jefferson Regional Medical Center	Clairton	Pennsylvania	United States	15025
424	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
425	Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center	DuBois	Pennsylvania	United States	15801
426	Dale and Frances Hughes Cancer Center at Pocono Medical Center	East Stroudsburg	Pennsylvania	United States	18301
427	Easton Regional Cancer Center at Easton Hospital	Easton	Pennsylvania	United States	18042
428	UPMC Cancer Center - Arnold Palmer Pavilion	Greensburg	Pennsylvania	United States	15601
429	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
430	UPMC Cancer Center at the John P. Murtha Pavilion	Johnstown	Pennsylvania	United States	15901
431	St. Mary Regional Cancer Center	Langhorne	Pennsylvania	United States	19047
432	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
433	Riddle Memorial Hospital Cancer Center	Media	Pennsylvania	United States	19063
434	UPMC - Moon	Moon	Pennsylvania	United States	15108
435	UPMC Cancer Center - Natrona Heights	Natrona Heights	Pennsylvania	United States	15065
436	Jameson Memorial Hospital - North Campus	New Castle	Pennsylvania	United States	16105
437	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
438	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
439	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
440	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
441	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
442	Frankford Hospital Cancer Center - Torresdale Campus	Philadelphia	Pennsylvania	United States	19114
443	Albert Einstein Cancer Center	Philadelphia	Pennsylvania	United States	19141
444	UPMC - Shadyside	Pittsburgh	Pennsylvania	United States	15213-2582
445	UPMC Cancer Center at UPMC St. Margaret	Pittsburgh	Pennsylvania	United States	15215
446	Mercy Cancer Institute at Mercy Hospital	Pittsburgh	Pennsylvania	United States	15219
447	UPMC Cancer Centers	Pittsburgh	Pennsylvania	United States	15232
448	UPMC Cancer Center at UPMC Passavant	Pittsburgh	Pennsylvania	United States	15237
449	St. Clair Memorial Hospital Cancer Center	Pittsburgh	Pennsylvania	United States	15243
450	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania	United States	18840
451	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania	United States	18501
452	Hematology and Oncology Associates of Northeastern Pennsylvania	Scranton	Pennsylvania	United States	18508
453	Grand View Hospital	Sellersville	Pennsylvania	United States	18960
454	UPMC Cancer Center at UPMC Northwest	Seneca	Pennsylvania	United States	16346
455	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
456	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
457	Washington Hospital Cancer Center	Washington	Pennsylvania	United States	15301
458	Jennersville Regional Hospital	West Grove	Pennsylvania	United States	19390-9499
459	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
460	CCOP - Main Line Health	Wynnewood	Pennsylvania	United States	19096
461	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
462	Hematology and Oncology Associates of Rhode Island	Cranston	Rhode Island	United States	02920
463	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island	United States	02860
464	Kent County Memorial Hospital	Warwick	Rhode Island	United States	02886
465	AnMed Cancer Center	Anderson	South Carolina	United States	29621
466	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina	United States	29401
467	CCOP - Greenville	Greenville	South Carolina	United States	29615
468	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
469	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
470	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
471	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
472	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
473	Blue Ridge Medical Specialists, PC	Bristol	Tennessee	United States	37620
474	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37662
475	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
476	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
477	Wilford Hall Medical Center	Lackland Air Force Base	Texas	United States	78236
478	Doctor's Hospital of Laredo	Laredo	Texas	United States	78041
479	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
480	American Fork Hospital	American Fork	Utah	United States	84003
481	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
482	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
483	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
484	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
485	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
486	LDS Hospital	Salt Lake City	Utah	United States	84103
487	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
488	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
489	Danville Regional Medical Center	Danville	Virginia	United States	24541
490	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
491	Virginia Oncology Associates - Hampton	Hampton	Virginia	United States	23666
492	Lynchburg Hematology-Oncology Clinic	Lynchburg	Virginia	United States	24501
493	Southwest Virginia Regional Cancer Center at Wellmonth Health	Norton	Virginia	United States	24273
494	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	United States	23298-0037
495	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
496	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
497	Columbia Basin Hematology	Kennewick	Washington	United States	99336
498	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
499	Harborview Medical Center	Seattle	Washington	United States	98104
500	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
501	Group Health Central Hospital	Seattle	Washington	United States	98112
502	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
503	Polyclinic First Hill	Seattle	Washington	United States	98122
504	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
505	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
506	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
507	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia	United States	25304
508	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital	Huntington	West Virginia	United States	25701
509	Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Parkersburg	West Virginia	United States	26102
510	Princeton Community Hospital	Princeton	West Virginia	United States	24740
511	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
512	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
513	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
514	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
515	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
516	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
517	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
518	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
519	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
520	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin	United States	53066
521	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
522	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
523	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
524	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
525	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin	United States	53188
526	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
527	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
528	Cross Cancer Institute at University of Alberta	Edmonton	Alberta	Canada	T6G 1Z2
529	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
530	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
531	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
532	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario	Canada	K7L 5P9
533	London Regional Cancer Program at London Health Sciences Centre	London	Ontario	Canada	N6A 4L6
534	Ottawa Hospital Regional Cancer Centre - General Campus	Ottawa	Ontario	Canada	K1H 1C4
535	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan	Canada	S4T 7T1

Sponsors and Collaborators

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

Investigators

Study Chair: Charles Fuchs, MD, MPH, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

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:

NCT00052910

Other Study ID Numbers:

CALGB-80101
U10CA031946
CDR0000258787

First Posted:

Jan 27, 2003

Last Update Posted:

May 7, 2020

Last Verified:

Apr 1, 2020

Keywords provided by Alliance for Clinical Trials in Oncology

stage I gastric cancer

stage II gastric cancer

stage III gastric cancer

adenocarcinoma of the stomach

adenocarcinoma of the esophagus

stage I esophageal cancer

stage II esophageal cancer

stage III esophageal cancer

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Arm I (5-FU/LV)	Arm II (ECF)
Arm/Group Description	Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.	Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Period Title: Overall Study
STARTED	280	266
COMPLETED	280	266
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm I (5-FU/LV)	Arm II (ECF)	Total
Arm/Group Description	Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.	Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.	Total of all reporting groups
Overall Participants	280	266	546
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59	58	58.6
Sex: Female, Male (Count of Participants)
Female	87 31.1%	88 33.1%	175 32.1%
Male	193 68.9%	178 66.9%	371 67.9%
Region of Enrollment (participants) [Number]
Canada	21 7.5%	17 6.4%	38 7%
United States	259 92.5%	249 93.6%	508 93%

Outcome Measures

1. Primary Outcome

Title	Overall Survival
Description	Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame	From study enrollment until death from any cause; up to 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm I (5-FU/LV)	Arm II (ECF)
Arm/Group Description	Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.	Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Measure Participants	280	266
Median (95% Confidence Interval) [years]	3.6	3.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (5-FU/LV), Arm II (ECF)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95% 0.79 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	Adjusted Hazard Ratio, ECF vs 5-FU/LV

2. Secondary Outcome

Title	Disease Free Survival
Description	Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.
Time Frame	From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm I (5-FU/LV)	Arm II (ECF)
Arm/Group Description	Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.	Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Measure Participants	280	266
Median (95% Confidence Interval) [years]	2.7	2.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (5-FU/LV), Arm II (ECF)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95% 0.83 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	Adjusted Hazard Ratio, ECF vs 5-FU/LV

Adverse Events

	Arm I (5-FU/LV)		Arm II (ECF)
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Arm I (5-FU/LV)		Arm II (ECF)
Arm/Group Description	Patients receive leucovorin calcium (LV) IV (20 mg/m^2 per day) and fluorouracil (5-FU) IV (425 mg/m^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.		Patients receive epirubicin IV (50 mg/m^2) over 3-15 minutes and cisplatin IV (60 mg/m^2) over 1 hour on day 1 and 5-FU IV (200 mg/m^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/272 (4%)		5/251 (2%)
Serious Adverse Events
	Arm I (5-FU/LV)		Arm II (ECF)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	62/272 (22.8%)		42/251 (16.7%)
Blood and lymphatic system disorders
Blood disorder	2/272 (0.7%)	2	1/251 (0.4%)	1
Febrile neutropenia	7/272 (2.6%)	8	0/251 (0%)	0
Hemoglobin decreased	7/272 (2.6%)	7	8/251 (3.2%)	10
Hemolysis	1/272 (0.4%)	1	1/251 (0.4%)	1
Transfusion: Platelets	0/272 (0%)	0	1/251 (0.4%)	1
Cardiac disorders
Arrhythmia supraventricular	2/272 (0.7%)	2	2/251 (0.8%)	2
Atrial tachycardia	1/272 (0.4%)	1	0/251 (0%)	0
Cardiac disorder	2/272 (0.7%)	2	0/251 (0%)	0
Edema	1/272 (0.4%)	1	1/251 (0.4%)	1
Left ventricular failure	0/272 (0%)	0	1/251 (0.4%)	1
Myocardial ischemia	1/272 (0.4%)	1	1/251 (0.4%)	1
Pericardial effusion	1/272 (0.4%)	1	0/251 (0%)	0
Sinus bradycardia	1/272 (0.4%)	1	0/251 (0%)	0
Sinus tachycardia	2/272 (0.7%)	2	2/251 (0.8%)	2
Ventricular arrhythmia	1/272 (0.4%)	1	0/251 (0%)	0
Eye disorders
Diplopia	1/272 (0.4%)	1	0/251 (0%)	0
Eye disorder	1/272 (0.4%)	1	0/251 (0%)	0
Vision blurred	1/272 (0.4%)	1	0/251 (0%)	0
Gastrointestinal disorders
Abdominal pain	27/272 (9.9%)	29	9/251 (3.6%)	9
Ascites	1/272 (0.4%)	1	0/251 (0%)	0
Colitis	5/272 (1.8%)	5	0/251 (0%)	0
Colonic obstruction	0/272 (0%)	0	1/251 (0.4%)	1
Constipation	2/272 (0.7%)	2	3/251 (1.2%)	3
Diarrhea	31/272 (11.4%)	32	10/251 (4%)	11
Dyspepsia	2/272 (0.7%)	2	4/251 (1.6%)	4
Dysphagia	6/272 (2.2%)	6	1/251 (0.4%)	1
Dysphagia-esophageal related to radiation	0/272 (0%)	0	1/251 (0.4%)	1
Esophagitis	5/272 (1.8%)	5	2/251 (0.8%)	2
Flatulence	1/272 (0.4%)	1	0/251 (0%)	0
Gastrointestinal disorder	5/272 (1.8%)	5	2/251 (0.8%)	2
Ileus	0/272 (0%)	0	3/251 (1.2%)	3
Mucositis oral	26/272 (9.6%)	27	5/251 (2%)	6
Nausea	40/272 (14.7%)	41	19/251 (7.6%)	20
Rectal pain	0/272 (0%)	0	1/251 (0.4%)	1
Vomiting	22/272 (8.1%)	24	15/251 (6%)	16
General disorders
Chest pain	2/272 (0.7%)	2	0/251 (0%)	0
Chills	0/272 (0%)	0	1/251 (0.4%)	1
Death NOS	1/272 (0.4%)	1	1/251 (0.4%)	1
Esophagus- Late RT Morbidity Scoring	1/272 (0.4%)	1	0/251 (0%)	0
Fatigue	32/272 (11.8%)	35	25/251 (10%)	28
Fever	2/272 (0.7%)	2	2/251 (0.8%)	3
Heart- Late RT Morbidity Scoring	1/272 (0.4%)	1	0/251 (0%)	0
Joint- Late RT Morbidity Scoring	0/272 (0%)	0	1/251 (0.4%)	1
Lung-Late RT Morbidity Scoring	0/272 (0%)	0	1/251 (0.4%)	1
Mucous membrane-Late RT Morbidity Scoring	1/272 (0.4%)	1	0/251 (0%)	0
Pain	1/272 (0.4%)	1	1/251 (0.4%)	1
Infections and infestations
Catheter related infection	2/272 (0.7%)	2	4/251 (1.6%)	4
Infection	2/272 (0.7%)	2	1/251 (0.4%)	1
Infection with grade 3 or 4 neutropenia	3/272 (1.1%)	3	1/251 (0.4%)	1
Infection without neutropenia	4/272 (1.5%)	4	1/251 (0.4%)	1
Pneumonia	0/272 (0%)	0	1/251 (0.4%)	1
Sepsis	1/272 (0.4%)	1	0/251 (0%)	0
Injury, poisoning and procedural complications
Dermatitis radiation	0/272 (0%)	0	1/251 (0.4%)	1
Fracture	1/272 (0.4%)	1	0/251 (0%)	0
Wound dehiscence	0/272 (0%)	0	1/251 (0.4%)	1
Investigations
Activated partial thromboplastin time prolonged	1/272 (0.4%)	1	1/251 (0.4%)	1
Alanine aminotransferase increased	1/272 (0.4%)	1	2/251 (0.8%)	2
Alkaline phosphatase increased	1/272 (0.4%)	1	1/251 (0.4%)	1
Amylase increased	1/272 (0.4%)	1	0/251 (0%)	0
Aspartate aminotransferase increased	2/272 (0.7%)	2	2/251 (0.8%)	2
Blood bilirubin increased	3/272 (1.1%)	3	1/251 (0.4%)	1
Creatinine increased	7/272 (2.6%)	7	3/251 (1.2%)	3
INR increased	2/272 (0.7%)	2	1/251 (0.4%)	1
Laboratory test abnormal	1/272 (0.4%)	1	1/251 (0.4%)	1
Leukocyte count decreased	24/272 (8.8%)	25	19/251 (7.6%)	21
Lymphocyte count decreased	5/272 (1.8%)	5	4/251 (1.6%)	5
Neutrophil count decreased	25/272 (9.2%)	26	20/251 (8%)	22
Platelet count decreased	14/272 (5.1%)	15	9/251 (3.6%)	10
Serum cholesterol increased	1/272 (0.4%)	1	0/251 (0%)	0
Weight gain	0/272 (0%)	0	1/251 (0.4%)	1
Weight loss	6/272 (2.2%)	6	7/251 (2.8%)	7
Metabolism and nutrition disorders
Acidosis	2/272 (0.7%)	2	1/251 (0.4%)	1
Alkalosis	0/272 (0%)	0	1/251 (0.4%)	1
Anorexia	27/272 (9.9%)	29	16/251 (6.4%)	18
Blood glucose increased	5/272 (1.8%)	5	3/251 (1.2%)	3
Dehydration	16/272 (5.9%)	16	9/251 (3.6%)	10
Serum albumin decreased	6/272 (2.2%)	6	2/251 (0.8%)	3
Serum calcium decreased	3/272 (1.1%)	3	4/251 (1.6%)	4
Serum glucose decreased	1/272 (0.4%)	1	2/251 (0.8%)	2
Serum magnesium decreased	1/272 (0.4%)	1	0/251 (0%)	0
Serum phosphate decreased	2/272 (0.7%)	2	0/251 (0%)	0
Serum potassium decreased	11/272 (4%)	12	3/251 (1.2%)	4
Serum sodium decreased	2/272 (0.7%)	2	1/251 (0.4%)	1
Serum sodium increased	0/272 (0%)	0	1/251 (0.4%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	2/272 (0.7%)	2	0/251 (0%)	0
Back pain	1/272 (0.4%)	1	0/251 (0%)	0
Muscle weakness	2/272 (0.7%)	2	0/251 (0%)	0
Musculoskeletal disorder	1/272 (0.4%)	1	1/251 (0.4%)	1
Nervous system disorders
Depressed level of consciousness	1/272 (0.4%)	1	2/251 (0.8%)	2
Dizziness	2/272 (0.7%)	2	0/251 (0%)	0
Dysgeusia	2/272 (0.7%)	2	1/251 (0.4%)	1
Headache	4/272 (1.5%)	4	0/251 (0%)	0
Intracranial hemorrhage	1/272 (0.4%)	1	0/251 (0%)	0
Memory impairment	1/272 (0.4%)	1	0/251 (0%)	0
Mini mental status examination abnormal	1/272 (0.4%)	1	0/251 (0%)	0
Neurological disorder NOS	1/272 (0.4%)	1	0/251 (0%)	0
Peripheral motor neuropathy	1/272 (0.4%)	1	1/251 (0.4%)	1
Peripheral sensory neuropathy	6/272 (2.2%)	6	4/251 (1.6%)	4
Speech disorder	1/272 (0.4%)	1	0/251 (0%)	0
Syncope	1/272 (0.4%)	1	1/251 (0.4%)	1
Psychiatric disorders
Confusion	2/272 (0.7%)	2	1/251 (0.4%)	1
Depression	2/272 (0.7%)	2	2/251 (0.8%)	3
Insomnia	1/272 (0.4%)	1	2/251 (0.8%)	2
Renal and urinary disorders
Renal failure	0/272 (0%)	0	1/251 (0.4%)	1
Urinary frequency	0/272 (0%)	0	1/251 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome	2/272 (0.7%)	2	0/251 (0%)	0
Cough	1/272 (0.4%)	1	1/251 (0.4%)	1
Dyspnea	2/272 (0.7%)	2	0/251 (0%)	0
Dyspnea (shortness of breath)	2/272 (0.7%)	2	1/251 (0.4%)	1
Hiccups	0/272 (0%)	0	1/251 (0.4%)	2
Hypoxia	2/272 (0.7%)	2	1/251 (0.4%)	1
Pleural effusion	2/272 (0.7%)	2	0/251 (0%)	0
Pleuritic pain	0/272 (0%)	0	1/251 (0.4%)	1
Pneumonitis	4/272 (1.5%)	4	0/251 (0%)	0
Respiratory disorder	1/272 (0.4%)	1	1/251 (0.4%)	1
Skin and subcutaneous tissue disorders
Alopecia	1/272 (0.4%)	1	1/251 (0.4%)	1
Dry skin	1/272 (0.4%)	1	0/251 (0%)	0
Hand-and-foot syndrome	7/272 (2.6%)	7	2/251 (0.8%)	2
Pruritus	1/272 (0.4%)	1	0/251 (0%)	0
Rash desquamating	3/272 (1.1%)	3	0/251 (0%)	0
Sweating	1/272 (0.4%)	1	0/251 (0%)	0
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia	0/272 (0%)	0	1/251 (0.4%)	1
Hypotension	7/272 (2.6%)	8	4/251 (1.6%)	4
Thrombosis	1/272 (0.4%)	1	3/251 (1.2%)	3
Other (Not Including Serious) Adverse Events
	Arm I (5-FU/LV)		Arm II (ECF)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	258/272 (94.9%)		234/251 (93.2%)
Blood and lymphatic system disorders
Blood disorder	2/272 (0.7%)	4	1/251 (0.4%)	2
Febrile neutropenia	10/272 (3.7%)	11	8/251 (3.2%)	10
Hemoglobin decreased	80/272 (29.4%)	165	81/251 (32.3%)	180
Hemoglobin for leukemia studies	0/272 (0%)	0	2/251 (0.8%)	2
Hemolysis	2/272 (0.7%)	2	1/251 (0.4%)	1
Lymphatic disorder	0/272 (0%)	0	1/251 (0.4%)	1
Thrombotic microangiopathy	1/272 (0.4%)	1	0/251 (0%)	0
Transfusion: pRBCs	1/272 (0.4%)	1	1/251 (0.4%)	1
Cardiac disorders
Arrhythmia	0/272 (0%)	0	1/251 (0.4%)	1
Arrhythmia supraventricular	1/272 (0.4%)	1	0/251 (0%)	0
Cardiac disorder	0/272 (0%)	0	6/251 (2.4%)	6
Cardiac pain	0/272 (0%)	0	1/251 (0.4%)	1
Conduction disorder	1/272 (0.4%)	1	0/251 (0%)	0
Edema	5/272 (1.8%)	5	2/251 (0.8%)	2
Myocardial ischemia	1/272 (0.4%)	1	0/251 (0%)	0
Palpitations	1/272 (0.4%)	2	0/251 (0%)	0
Pericarditis	1/272 (0.4%)	4	0/251 (0%)	0
Sinus bradycardia	1/272 (0.4%)	2	1/251 (0.4%)	1
Sinus tachycardia	4/272 (1.5%)	4	1/251 (0.4%)	1
Supraventricular tachycardia	1/272 (0.4%)	1	0/251 (0%)	0
Ventricular tachycardia	0/272 (0%)	0	1/251 (0.4%)	1
Ear and labyrinth disorders
Ear disorder	0/272 (0%)	0	1/251 (0.4%)	1
Ear pain	0/272 (0%)	0	1/251 (0.4%)	2
Hearing impaired	0/272 (0%)	0	3/251 (1.2%)	3
Hearing test abnormal	0/272 (0%)	0	1/251 (0.4%)	1
Middle ear inflammation	0/272 (0%)	0	1/251 (0.4%)	1
Tinnitus	0/272 (0%)	0	2/251 (0.8%)	2
Eye disorders
Dry eye syndrome	1/272 (0.4%)	1	0/251 (0%)	0
Eye disorder	3/272 (1.1%)	6	2/251 (0.8%)	3
Flashing vision	0/272 (0%)	0	1/251 (0.4%)	1
Vision blurred	2/272 (0.7%)	3	1/251 (0.4%)	1
Watering eyes	2/272 (0.7%)	3	2/251 (0.8%)	2
Gastrointestinal disorders
Abdominal distension	1/272 (0.4%)	1	2/251 (0.8%)	2
Abdominal pain	109/272 (40.1%)	186	94/251 (37.5%)	141
Ascites	1/272 (0.4%)	1	2/251 (0.8%)	2
Colitis	4/272 (1.5%)	5	0/251 (0%)	0
Constipation	37/272 (13.6%)	54	40/251 (15.9%)	59
Diarrhea	162/272 (59.6%)	313	120/251 (47.8%)	227
Dry mouth	4/272 (1.5%)	6	5/251 (2%)	6
Duodenal ulcer	1/272 (0.4%)	1	0/251 (0%)	0
Dyspepsia	18/272 (6.6%)	24	21/251 (8.4%)	35
Dysphagia	24/272 (8.8%)	29	23/251 (9.2%)	37
Dysphagia-esophageal related to radiation	2/272 (0.7%)	2	1/251 (0.4%)	1
Ear, nose and throat examination abnormal	1/272 (0.4%)	1	1/251 (0.4%)	1
Enteritis	1/272 (0.4%)	1	1/251 (0.4%)	1
Esophageal pain	0/272 (0%)	0	1/251 (0.4%)	1
Esophageal stenosis	2/272 (0.7%)	2	0/251 (0%)	0
Esophagitis	11/272 (4%)	14	13/251 (5.2%)	15
Fistula of small intestine	2/272 (0.7%)	2	0/251 (0%)	0
Flatulence	10/272 (3.7%)	13	4/251 (1.6%)	9
Gastric hemorrhage	0/272 (0%)	0	1/251 (0.4%)	1
Gastric stenosis	0/272 (0%)	0	1/251 (0.4%)	1
Gastric ulcer	1/272 (0.4%)	1	0/251 (0%)	0
Gastritis	7/272 (2.6%)	8	7/251 (2.8%)	9
Gastrointestinal disorder	8/272 (2.9%)	9	7/251 (2.8%)	8
Hemorrhoids	1/272 (0.4%)	3	1/251 (0.4%)	1
Ileus	2/272 (0.7%)	2	2/251 (0.8%)	2
Malabsorption	0/272 (0%)	0	1/251 (0.4%)	1
Mucositis due to radiation	0/272 (0%)	0	1/251 (0.4%)	1
Mucositis oral	155/272 (57%)	248	107/251 (42.6%)	168
Nausea	192/272 (70.6%)	390	176/251 (70.1%)	425
Oral pain	4/272 (1.5%)	4	1/251 (0.4%)	1
Pancreatitis	1/272 (0.4%)	1	0/251 (0%)	0
Proctitis	2/272 (0.7%)	2	0/251 (0%)	0
Rectal bleeding/hematochezia	0/272 (0%)	0	1/251 (0.4%)	1
Rectal hemorrhage	0/272 (0%)	0	1/251 (0.4%)	4
Salivary gland disorder	0/272 (0%)	0	2/251 (0.8%)	2
Small intestinal obstruction	0/272 (0%)	0	2/251 (0.8%)	2
Stomach pain	0/272 (0%)	0	3/251 (1.2%)	4
Vomiting	123/272 (45.2%)	191	120/251 (47.8%)	209
General disorders
Bladder- Late RT Morbidity Scoring	0/272 (0%)	0	3/251 (1.2%)	3
Bone - Late RT Morbidity Scoring	0/272 (0%)	0	2/251 (0.8%)	2
Brain- Late RT Morbidity Scoring	1/272 (0.4%)	1	2/251 (0.8%)	2
Chest pain	5/272 (1.8%)	7	8/251 (3.2%)	10
Chills	3/272 (1.1%)	5	3/251 (1.2%)	4
Edema limbs	3/272 (1.1%)	3	7/251 (2.8%)	10
Esophagus- Late RT Morbidity Scoring	19/272 (7%)	63	19/251 (7.6%)	32
Facial pain	0/272 (0%)	0	1/251 (0.4%)	1
Fatigue	201/272 (73.9%)	493	190/251 (75.7%)	503
Fever	10/272 (3.7%)	11	6/251 (2.4%)	6
Flu-like symptoms	1/272 (0.4%)	1	0/251 (0%)	0
General symptom	2/272 (0.7%)	2	3/251 (1.2%)	4
Heart- Late RT Morbidity Scoring	3/272 (1.1%)	4	4/251 (1.6%)	7
Ill-defined disorder	2/272 (0.7%)	2	1/251 (0.4%)	1
Joint- Late RT Morbidity Scoring	2/272 (0.7%)	2	1/251 (0.4%)	1
Kidney-Late RT Morbidity Scoring	3/272 (1.1%)	3	3/251 (1.2%)	6
Larynx-Late RT Morbidity Scoring	2/272 (0.7%)	2	1/251 (0.4%)	2
Liver-Late RT Morbidity Scoring	6/272 (2.2%)	17	4/251 (1.6%)	7
Localized edema	1/272 (0.4%)	1	1/251 (0.4%)	1
Lung-Late RT Morbidity Scoring	8/272 (2.9%)	11	6/251 (2.4%)	14
Mucous membrane-Late RT Morbidity Scoring	3/272 (1.1%)	3	4/251 (1.6%)	5
Pain	19/272 (7%)	31	23/251 (9.2%)	32
Pericardial pain	0/272 (0%)	0	1/251 (0.4%)	1
Radiation-Other(Specify,_____)	17/272 (6.3%)	24	11/251 (4.4%)	28
Salivary glands-Late RT Morbidity Scoring	1/272 (0.4%)	1	1/251 (0.4%)	1
Skin-Late RT Morbidity Scoring	6/272 (2.2%)	6	3/251 (1.2%)	3
Small/Large intestine-Late RT Morbidity Scoring	12/272 (4.4%)	16	12/251 (4.8%)	23
Subcutaneous tissue-Late RT Morbidity Scoring	1/272 (0.4%)	1	0/251 (0%)	0
Hepatobiliary disorders
Hepatobiliary disease	3/272 (1.1%)	6	1/251 (0.4%)	1
Portal hypertension	1/272 (0.4%)	2	0/251 (0%)	0
Immune system disorders
Hypersensitivity	0/272 (0%)	0	1/251 (0.4%)	1
Infections and infestations
Abdominal infection	2/272 (0.7%)	2	0/251 (0%)	0
Bladder infection	2/272 (0.7%)	4	0/251 (0%)	0
Bronchitis	1/272 (0.4%)	1	1/251 (0.4%)	1
Catheter related infection	1/272 (0.4%)	2	5/251 (2%)	6
Device related infection	1/272 (0.4%)	2	2/251 (0.8%)	2
Esophageal infection	1/272 (0.4%)	1	2/251 (0.8%)	2
Infection	10/272 (3.7%)	13	1/251 (0.4%)	1
Infection with grade 3 or 4 neutropenia	4/272 (1.5%)	4	2/251 (0.8%)	3
Infection with unknown ANC	0/272 (0%)	0	1/251 (0.4%)	1
Infection without neutropenia	6/272 (2.2%)	6	7/251 (2.8%)	7
Infectious colitis	3/272 (1.1%)	3	0/251 (0%)	0
Opportunistic infection	0/272 (0%)	0	2/251 (0.8%)	3
Paranasal sinus infection	0/272 (0%)	0	1/251 (0.4%)	1
Penile infection	0/272 (0%)	0	1/251 (0.4%)	1
Peripheral nerve infection	0/272 (0%)	0	2/251 (0.8%)	3
Pneumonia	0/272 (0%)	0	1/251 (0.4%)	1
Sepsis	0/272 (0%)	0	1/251 (0.4%)	1
Sinusitis	1/272 (0.4%)	1	1/251 (0.4%)	1
Skin infection	1/272 (0.4%)	1	2/251 (0.8%)	3
Stoma site infection	0/272 (0%)	0	1/251 (0.4%)	1
Tooth infection	1/272 (0.4%)	1	0/251 (0%)	0
Ureteritis	0/272 (0%)	0	1/251 (0.4%)	1
Urinary tract infection	0/272 (0%)	0	2/251 (0.8%)	2
Wound infection	2/272 (0.7%)	2	2/251 (0.8%)	3
Wound-infectious	2/272 (0.7%)	2	0/251 (0%)	0
Injury, poisoning and procedural complications
Dermatitis radiation	23/272 (8.5%)	26	16/251 (6.4%)	21
Fracture	1/272 (0.4%)	1	0/251 (0%)	0
Intraoperative gastrointestinal injury - Appendix	1/272 (0.4%)	1	0/251 (0%)	0
Thermal burn	0/272 (0%)	0	1/251 (0.4%)	1
Vascular access complication	3/272 (1.1%)	3	1/251 (0.4%)	1
Wound dehiscence	0/272 (0%)	0	1/251 (0.4%)	2
Investigations
Activated partial thromboplastin time prolonged	4/272 (1.5%)	4	1/251 (0.4%)	1
Alanine aminotransferase increased	21/272 (7.7%)	34	22/251 (8.8%)	36
Alkaline phosphatase	4/272 (1.5%)	8	5/251 (2%)	7
Alkaline phosphatase increased	22/272 (8.1%)	32	17/251 (6.8%)	23
Amylase increased	1/272 (0.4%)	1	1/251 (0.4%)	1
Aspartate aminotransferase increased	36/272 (13.2%)	54	28/251 (11.2%)	36
Blood bilirubin increased	16/272 (5.9%)	22	7/251 (2.8%)	8
Coagulopathy	5/272 (1.8%)	6	0/251 (0%)	0
Creatine phosphokinase increased	1/272 (0.4%)	1	0/251 (0%)	0
Creatinine increased	22/272 (8.1%)	29	17/251 (6.8%)	34
Gamma-glutamyltransferase increased	2/272 (0.7%)	4	2/251 (0.8%)	4
Haptoglobin decreased	1/272 (0.4%)	1	0/251 (0%)	0
INR increased	4/272 (1.5%)	5	2/251 (0.8%)	2
Laboratory test abnormal	3/272 (1.1%)	5	4/251 (1.6%)	4
Leukocyte count decreased	177/272 (65.1%)	409	177/251 (70.5%)	458
Lipase increased	1/272 (0.4%)	1	1/251 (0.4%)	1
Lymphocyte count decreased	39/272 (14.3%)	75	32/251 (12.7%)	67
Neutrophil count decreased	178/272 (65.4%)	333	166/251 (66.1%)	361
Platelet count decreased	92/272 (33.8%)	167	74/251 (29.5%)	145
Weight gain	0/272 (0%)	0	3/251 (1.2%)	3
Weight loss	59/272 (21.7%)	96	51/251 (20.3%)	90
Metabolism and nutrition disorders
Acidosis	0/272 (0%)	0	1/251 (0.4%)	2
Alkalosis	0/272 (0%)	0	1/251 (0.4%)	1
Anorexia	148/272 (54.4%)	279	140/251 (55.8%)	294
Blood bicarbonate decreased	2/272 (0.7%)	2	0/251 (0%)	0
Blood glucose increased	41/272 (15.1%)	66	47/251 (18.7%)	77
Dehydration	33/272 (12.1%)	45	31/251 (12.4%)	45
Serum albumin decreased	32/272 (11.8%)	40	28/251 (11.2%)	44
Serum calcium decreased	28/272 (10.3%)	38	23/251 (9.2%)	28
Serum glucose decreased	5/272 (1.8%)	8	10/251 (4%)	13
Serum magnesium decreased	5/272 (1.8%)	7	10/251 (4%)	17
Serum magnesium increased	2/272 (0.7%)	2	3/251 (1.2%)	4
Serum phosphate decreased	2/272 (0.7%)	2	1/251 (0.4%)	2
Serum potassium decreased	31/272 (11.4%)	44	26/251 (10.4%)	43
Serum potassium increased	7/272 (2.6%)	8	4/251 (1.6%)	4
Serum sodium decreased	24/272 (8.8%)	32	14/251 (5.6%)	24
Serum sodium increased	2/272 (0.7%)	2	1/251 (0.4%)	1
Serum triglycerides increased	1/272 (0.4%)	1	0/251 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	8/272 (2.9%)	14	6/251 (2.4%)	7
Arthritis	1/272 (0.4%)	1	2/251 (0.8%)	5
Back pain	7/272 (2.6%)	12	11/251 (4.4%)	14
Bone pain	4/272 (1.5%)	5	0/251 (0%)	0
Chest wall pain	1/272 (0.4%)	1	3/251 (1.2%)	3
Muscle weakness	4/272 (1.5%)	5	2/251 (0.8%)	5
Muscle weakness lower limb	1/272 (0.4%)	1	0/251 (0%)	0
Musculoskeletal disorder	1/272 (0.4%)	2	2/251 (0.8%)	3
Myalgia	7/272 (2.6%)	8	4/251 (1.6%)	7
Neck pain	1/272 (0.4%)	3	0/251 (0%)	0
Pain in extremity	1/272 (0.4%)	1	5/251 (2%)	7
Nervous system disorders
Ataxia	2/272 (0.7%)	2	2/251 (0.8%)	2
Depressed level of consciousness	1/272 (0.4%)	1	0/251 (0%)	0
Dizziness	15/272 (5.5%)	18	22/251 (8.8%)	33
Dysgeusia	27/272 (9.9%)	41	20/251 (8%)	39
Extrapyramidal disorder	0/272 (0%)	0	1/251 (0.4%)	1
Headache	13/272 (4.8%)	17	17/251 (6.8%)	23
Memory impairment	0/272 (0%)	0	1/251 (0.4%)	2
Neuralgia	0/272 (0%)	0	2/251 (0.8%)	4
Neurological disorder NOS	2/272 (0.7%)	4	0/251 (0%)	0
Neuropathy - cranial	1/272 (0.4%)	1	0/251 (0%)	0
Peripheral motor neuropathy	2/272 (0.7%)	2	5/251 (2%)	6
Peripheral sensory neuropathy	34/272 (12.5%)	55	38/251 (15.1%)	62
Syncope	3/272 (1.1%)	3	4/251 (1.6%)	4
Syncope vasovagal	0/272 (0%)	0	3/251 (1.2%)	3
Tremor	2/272 (0.7%)	3	3/251 (1.2%)	4
Psychiatric disorders
Anxiety	5/272 (1.8%)	7	12/251 (4.8%)	27
Depression	9/272 (3.3%)	13	18/251 (7.2%)	29
Euphoria	1/272 (0.4%)	1	0/251 (0%)	0
Insomnia	17/272 (6.3%)	22	16/251 (6.4%)	23
Libido decreased	1/272 (0.4%)	1	0/251 (0%)	0
Renal and urinary disorders
Bladder pain	1/272 (0.4%)	1	1/251 (0.4%)	1
Hematuria (in the absence of vaginal bleeding)	0/272 (0%)	0	1/251 (0.4%)	1
Hemoglobin urine positive	1/272 (0.4%)	1	1/251 (0.4%)	2
Incontinence	1/272 (0.4%)	1	0/251 (0%)	0
Proteinuria	0/272 (0%)	0	2/251 (0.8%)	2
Ureteric obstruction	1/272 (0.4%)	1	1/251 (0.4%)	1
Urinary frequency	3/272 (1.1%)	3	4/251 (1.6%)	5
Urinary retention	0/272 (0%)	0	1/251 (0.4%)	3
Urine discoloration	1/272 (0.4%)	1	0/251 (0%)	0
Urogenital disorder	0/272 (0%)	0	1/251 (0.4%)	1
Reproductive system and breast disorders
Irregular menstruation	0/272 (0%)	0	1/251 (0.4%)	1
Vaginal inflammation	1/272 (0.4%)	1	0/251 (0%)	0
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	4/272 (1.5%)	7	2/251 (0.8%)	3
Aspiration	1/272 (0.4%)	1	0/251 (0%)	0
Bronchospasm	1/272 (0.4%)	1	0/251 (0%)	0
Cough	25/272 (9.2%)	35	18/251 (7.2%)	25
Dyspnea	9/272 (3.3%)	13	7/251 (2.8%)	12
Dyspnea (shortness of breath)	6/272 (2.2%)	8	5/251 (2%)	7
Epistaxis	8/272 (2.9%)	9	7/251 (2.8%)	7
Hiccups	1/272 (0.4%)	1	7/251 (2.8%)	7
Hypoxia	1/272 (0.4%)	1	0/251 (0%)	0
Nasal congestion	1/272 (0.4%)	1	0/251 (0%)	0
Pharyngolaryngeal pain	3/272 (1.1%)	3	4/251 (1.6%)	4
Pleural effusion	1/272 (0.4%)	1	5/251 (2%)	6
Pleuritic pain	1/272 (0.4%)	1	0/251 (0%)	0
Pneumonitis	2/272 (0.7%)	4	1/251 (0.4%)	1
Respiratory disorder	4/272 (1.5%)	4	3/251 (1.2%)	3
Respiratory tract hemorrhage	2/272 (0.7%)	3	0/251 (0%)	0
Voice alteration	3/272 (1.1%)	6	2/251 (0.8%)	2
Skin and subcutaneous tissue disorders
Alopecia	21/272 (7.7%)	37	49/251 (19.5%)	104
Decubitus ulcer	1/272 (0.4%)	3	0/251 (0%)	0
Dermatology	1/272 (0.4%)	1	0/251 (0%)	0
Dry skin	9/272 (3.3%)	12	6/251 (2.4%)	8
Erythema multiforme	1/272 (0.4%)	3	1/251 (0.4%)	1
Hand-and-foot syndrome	36/272 (13.2%)	52	46/251 (18.3%)	75
Nail disorder	4/272 (1.5%)	4	14/251 (5.6%)	21
Photosensitivity	0/272 (0%)	0	1/251 (0.4%)	1
Pigmentation changes (e.g., vitiligo)	0/272 (0%)	0	2/251 (0.8%)	6
Pruritus	6/272 (2.2%)	11	4/251 (1.6%)	7
Rash acneiform	1/272 (0.4%)	2	1/251 (0.4%)	1
Rash desquamating	30/272 (11%)	39	13/251 (5.2%)	16
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.	1/272 (0.4%)	1	0/251 (0%)	0
Skin disorder	7/272 (2.6%)	10	3/251 (1.2%)	3
Skin hyperpigmentation	5/272 (1.8%)	8	7/251 (2.8%)	9
Sweating	2/272 (0.7%)	2	6/251 (2.4%)	7
Vascular disorders
Flushing	4/272 (1.5%)	7	2/251 (0.8%)	3
Hemorrhage	2/272 (0.7%)	2	0/251 (0%)	0
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	1/272 (0.4%)	1	0/251 (0%)	0
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia	1/272 (0.4%)	1	1/251 (0.4%)	1
Hot flashes	1/272 (0.4%)	1	2/251 (0.8%)	2
Hypertension	0/272 (0%)	0	4/251 (1.6%)	5
Hypotension	7/272 (2.6%)	10	11/251 (4.4%)	14
Phlebitis	1/272 (0.4%)	1	0/251 (0%)	0
Thrombosis	6/272 (2.2%)	7	10/251 (4%)	10

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Charles S. Fuchs, MD, MPH
Organization	Yale Cancer Center
Phone	(203) 785-4095
Email	charles.fuchs@yale.edu

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00052910

Other Study ID Numbers:

CALGB-80101
U10CA031946
CDR0000258787

First Posted:

Jan 27, 2003

Last Update Posted:

May 7, 2020

Last Verified:

Apr 1, 2020

Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer

Study Details

Study Description

Brief Summary

Detailed Description

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

Study Documents (Full-Text)

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Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact