Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer

• Sponsor: ECOG-ACRIN Cancer Research Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00008385
• Collaborator: National Cancer Institute (NCI) (NIH), Southwest Oncology Group (Other), North Central Cancer Treatment Group (Other), NCIC Clinical Trials Group (Other), Cancer and Leukemia Group B (Other)
• Enrollment: 1,772
• Locations: 532
• Arms: 2
• Actual Duration (Months): 229
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known if selenium is effective in preventing the growth of new tumors in patients with previously resected non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared to a placebo in preventing the development of second primary lung tumors in patients who have undergone surgery to remove stage I non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: placebo; Drug: selenium	Phase 3

Detailed Description

OBJECTIVES:

Primary Objective:

• Determine the efficacy of selenium in terms of reducing the incidence of second primary lung tumors in participants with previously resected stage I non-small cell lung cancer.

Secondary Objectives:

• Evaluate the qualitative and quantitative toxicity of selenium in these patients.

• Compare the incidence of specific cancers, mortality from cancer, and overall survival of participants treated with selenium vs those treated with placebo.

OUTLINE: This is a randomized, double-blinded, placebo-controlled, multicenter study. Participants are stratified according to smoking status (actively smoking or stopped less than 1 year ago vs. stopped at least 1 year ago vs. never smoked or no more than 100 cigarettes ever), gender, and stage and previous therapy (stage IA vs. stage IB with previous therapy vs. stage IB with no previous therapy). Participants are randomized in a 1:2 ratio to arm I and arm II.

• Arm I: Participants receive an oral yeast placebo as in arm II.

• Arm II: Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.

Participants are followed annually (every 12 months) for 10 years.

PROJECTED ACCRUAL: A total of 1,960 participants will be accrued for this study within 4 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1772 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer
• Actual Study Start Date: Oct 1, 2000
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm I Participants receive an oral yeast placebo as in arm II.	Other: placebo; Given orally
Experimental: Arm II Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.	Drug: selenium; Given orally; Other Names: L-selenomethionine

Outcome Measures

Primary Outcome Measures

1. Incidence Rate of Second Primary Lung Tumor [Assessed annually for 10 years after randomization]

   Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.

Secondary Outcome Measures

1. 5-year Progression-free Survival Rate [Assessed annually for 5 years after randomization]

   Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate. Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer. Different histologic type Location in different lobe Location in contralateral lung Occurrence > 5 years after initial diagnosis

2. 5-year Overall Survival Rate [Assessed annually for 5 years after randomization]

   Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

RUN-IN PERIOD:

Inclusion Criteria:

• Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small lung cancer (except carcinoid)*

• Completion of treatment for stage I lung cancer within the past 6 to 36 months and currently disease free

• At least one mediastinal lymph node sampled at resection NOTE: *Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (CALGB) patients must be T1, N0; CALGB patients may be T2, N0 provided disease was completely resected prior to June 1, 2001 and participation in CALGB 9633 was refused if offered

• 18 years old and over

• Eastern Cooperative Oncology Group performance status 0-1

• Bilirubin no greater than upper limit of normal (ULN)

• Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN

• Prior mineral, herbal, phytochemical, or vitamin supplementation allowed

• Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged

Exclusion Criteria:

• Evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks

• Synchronous lung or non-lung lesions or metastasis, even if resectable

• History of more than one primary lung cancer at any time

• Concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer

• Prior or concurrent chemotherapy for recurrent lung cancer

• Prior or concurrent radiotherapy for recurrent lung cancer

• Concurrent surgery

• Concurrent supplement(s) containing more than 50 micrograms of selenium

STUDY PHASE:

• Free of disease

• Consumed at least 75% of tablets during 4-week run-in period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36604
2	Providence Cancer Center at Providence Hospital	Mobile	Alabama	United States	36608
3	Arizona Oncology Services Foundation	Phoenix	Arizona	United States	85013
4	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn	Scottsdale	Arizona	United States	85251
5	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
6	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea	Scottsdale	Arizona	United States	85260
7	Highlands Oncology Group - Springdale	Bentonville	Arkansas	United States	72712
8	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
9	East Bay Radiation Oncology Center	Castro Valley	California	United States	94546
10	Eden Medical Center	Castro Valley	California	United States	94546
11	North Bay Cancer Center	Fairfield	California	United States	94533
12	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
13	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
14	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
15	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California	United States	95901
16	Memorial Medical Center	Modesto	California	United States	95355
17	El Camino Hospital Cancer Center	Mountain View	California	United States	94040
18	Highland General Hospital	Oakland	California	United States	94602
19	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
20	Bay Area Breast Surgeons, Incorporated	Oakland	California	United States	94609
21	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
22	Larry G Strieff MD Medical Corporation	Oakland	California	United States	94609
23	Tom K Lee, Incorporated	Oakland	California	United States	94609
24	Veterans Affairs Medical Center - Palo Alto	Palo Alto	California	United States	94304
25	Valley Care Medical Center	Pleasanton	California	United States	94588
26	Valley Medical Oncology Consultants - Pleasanton	Pleasanton	California	United States	94588
27	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center	Pomona	California	United States	91767
28	Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center	Rancho Mirage	California	United States	92270
29	University of California Davis Cancer Center	Sacramento	California	United States	95817
30	Mercy General Hospital	Sacramento	California	United States	95819
31	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California	United States	92120
32	Doctors Medical Center - San Pablo Campus	San Pablo	California	United States	94806
33	Stanford Cancer Center	Stanford	California	United States	94305-5824
34	Tahoe Forest Cancer Center	Truckee	California	United States	96161
35	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
36	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
37	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
38	St. Anthony Central Hospital	Denver	Colorado	United States	80204
39	Porter Adventist Hospital	Denver	Colorado	United States	80210
40	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
41	St. Joseph Hospital	Denver	Colorado	United States	80218
42	Rose Medical Center	Denver	Colorado	United States	80220
43	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80224-2522
44	Swedish Medical Center	Englewood	Colorado	United States	80110
45	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
46	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
47	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
48	North Colorado Medical Center	Greeley	Colorado	United States	80631
49	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
50	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
51	McKee Medical Center	Loveland	Colorado	United States	80539
52	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
53	North Suburban Medical Center	Thornton	Colorado	United States	80229
54	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
55	Praxair Cancer Center at Danbury Hospital	Danbury	Connecticut	United States	06810
56	Helen and Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut	United States	06102-5037
57	Hospital of Saint Raphael	New Haven	Connecticut	United States	06511
58	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut	United States	06360
59	Connecticut Oncology & Hematology - Torrington	Torrington	Connecticut	United States	06790
60	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
61	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
62	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
63	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
64	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida	United States	32504
65	West Florida Cancer Institute at West Florida Hospital - Pensacola	Pensacola	Florida	United States	32514
66	Piedmont Hospital	Atlanta	Georgia	United States	30309
67	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
68	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342-1611
69	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342-1701
70	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
71	WellStar Cobb Hospital	Austell	Georgia	United States	30106
72	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
73	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
74	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
75	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
76	Southern Regional Medical Center	Riverdale	Georgia	United States	30274-2600
77	Harbin Clinic Cancer Center - Medical Oncology	Rome	Georgia	United States	30165
78	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia	United States	31405
79	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia	United States	31603
80	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii	United States	96701
81	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
82	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
83	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
84	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
85	Hawaii Medical Center - East	Honolulu	Hawaii	United States	96817
86	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817
87	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
88	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
89	Maui Memorial Medical Center	Wailuku	Hawaii	United States	96793
90	Pacific Cancer Institute - Maui	Wailuku	Hawaii	United States	96793
91	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
92	Hematology Oncology Associates of Illinois - Berwyn	Berwyn	Illinois	United States	60402
93	Illinois CancerCare - Bloomington	Bloomington	Illinois	United States	61701
94	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
95	Graham Hospital	Canton	Illinois	United States	61520
96	Illinois CancerCare - Canton	Canton	Illinois	United States	61520
97	Illinois CancerCare - Carthage	Carthage	Illinois	United States	62321
98	Memorial Hospital	Carthage	Illinois	United States	62321
99	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
100	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
101	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois	United States	60612-3785
102	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
103	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois	United States	60612
104	Saint Joseph Hospital	Chicago	Illinois	United States	60657
105	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
106	Sherman Hospital	Elgin	Illinois	United States	60120
107	Alexian Brothers Radiation Oncology	Elk Grove Village	Illinois	United States	60007
108	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
109	Eureka Community Hospital	Eureka	Illinois	United States	61530
110	Illinois CancerCare - Eureka	Eureka	Illinois	United States	61530
111	Evanston Hospital	Evanston	Illinois	United States	60201-1781
112	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
113	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
114	Illinois CancerCare - Galesburg	Galesburg	Illinois	United States	61401
115	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
116	Illinois CancerCare - Havana	Havana	Illinois	United States	62644
117	Mason District Hospital	Havana	Illinois	United States	62644
118	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
119	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
120	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois	United States	61443
121	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
122	Illinois CancerCare - Macomb	Macomb	Illinois	United States	61455
123	McDonough District Hospital	Macomb	Illinois	United States	61455
124	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
125	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois	United States	61265
126		Moline	Illinois	United States	61265
127	Illinois CancerCare - Monmouth	Monmouth	Illinois	United States	61462
128	OSF Holy Family Medical Center	Monmouth	Illinois	United States	61462
129	La Grange Oncology Associates - Geneva	Naperville	Illinois	United States	60563
130	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois	United States	60714
131	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
132	Community Cancer Center	Normal	Illinois	United States	61761
133	Illinois CancerCare - Community Cancer Center	Normal	Illinois	United States	61761
134	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
135	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
136	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
137	Illinois CancerCare - Pekin	Pekin	Illinois	United States	61603
138	Proctor Hospital	Peoria	Illinois	United States	61614
139	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
140	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
141	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
142	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
143	Illinois CancerCare - Peru	Peru	Illinois	United States	61354
144	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
145	Illinois CancerCare - Princeton	Princeton	Illinois	United States	61356
146	Swedish-American Regional Cancer Center	Rockford	Illinois	United States	61104-2315
147	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
148	Illinois CancerCare - Spring Valley	Spring Valley	Illinois	United States	61362
149	St. Margaret's Hospital	Spring Valley	Illinois	United States	61362
150	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
151	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
152	Elkhart General Hospital	Elkhart	Indiana	United States	46515
153	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
154	Veterans Affairs Medical Center - Indianapolis	Indianapolis	Indiana	United States	46202
155	William N. Wishard Memorial Hospital	Indianapolis	Indiana	United States	46202
156	Howard Community Hospital	Kokomo	Indiana	United States	46904
157	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
158	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
159	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
160	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
161	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
162	South Bend Clinic	South Bend	Indiana	United States	46617
163	McFarland Clinic, PC	Ames	Iowa	United States	50010
164		Bettendorf	Iowa	United States	52722
165	Iowa Blood and Cancer Care	Cedar Rapids	Iowa	United States	52402
166	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
167	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
168	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
169	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
170	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
171	McCreery Cancer Center at Ottumwa Regional	Ottumwa	Iowa	United States	52501
172	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
173	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
174	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
175	Hospital District Sixth of Harper County	Anthony	Kansas	United States	67003
176	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
177	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
178	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
179	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
180	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
181	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
182	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
183	Southwest Medical Center	Liberal	Kansas	United States	67901
184	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
185	Menorah Medical Center	Overland Park	Kansas	United States	66209
186	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
187	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
188	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
189	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
190	Shawnee Mission Medical Center	Shawnee Mission	Kansas	United States	66204
191	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
192	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
193	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
194	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
195	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
196	CCOP - Wichita	Wichita	Kansas	United States	67214
197	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
198	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
199	Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County	Madisonville	Kentucky	United States	42431
200	Mitchell Memorial Cancer Center at Owensboro Medical Health System	Owensboro	Kentucky	United States	42303
201	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana	United States	71315-3198
202	Ochsner Health Center - Bluebonnet	Baton Rouge	Louisiana	United States	70809
203	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
204	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
205	York Hospital's Oncology Treatment Center	York	Maine	United States	03909
206	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland	United States	21204
207	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
208	Union Hospital Cancer Program at Union Hospital	Elkton	Maryland	United States	21921
209	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
210	Caritas St. Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135-2997
211	Cape Cod Hospital	Hyannis	Massachusetts	United States	02601
212	Caritas Norwood Hospital	Norwood	Massachusetts	United States	02062
213	Baystate Regional Cancer Program at D'Amour Center for Cancer Care	Springfield	Massachusetts	United States	01199
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	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
220	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
221	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
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	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan	United States	48910
236	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
237	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
238	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
239	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
240	Mercy General Health Partners	Muskegon	Michigan	United States	49443
241	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
242	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
243	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
244	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
245	Lakeland Regional Cancer Care Center - St. Joseph	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	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
251	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
252	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
253	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
254	CCOP - Duluth	Duluth	Minnesota	United States	55805
255	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
256	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
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	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
260	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota	United States	55109
261	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
262	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
263	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
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	United Hospital	Saint Paul	Minnesota	United States	55102
273	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
274	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
275	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota	United States	56201
276	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota	United States	55125
277	Hattiesburg Clinic, PA at Forrest General	Hattiesburg	Mississippi	United States	39401
278	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
279	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
280	St. Joseph Medical Center	Kansas City	Missouri	United States	64114
281	North Kansas City Hospital	Kansas City	Missouri	United States	64116
282	CCOP - Kansas City	Kansas City	Missouri	United States	64131
283	Research Medical Center	Kansas City	Missouri	United States	64132
284	Liberty Hospital	Liberty	Missouri	United States	64068
285	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
286	Christian Hospital Northeast Cancer Care Center	Saint Louis	Missouri	United States	63136
287	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
288	St. John's Regional Health Center	Springfield	Missouri	United States	65804
289	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
290	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
291	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
292	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
293	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
294	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
295	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
296	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
297	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
298	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
299		Great Falls	Montana	United States	59405
300	Northern Montana Hospital	Havre	Montana	United States	59501
301	St. Peter's Hospital	Helena	Montana	United States	59601
302	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
303	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
304	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
305	Community Medical Center	Missoula	Montana	United States	59801
306	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
307	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
308	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
309	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska	United States	68848-1990
310	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
311	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
312	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
313	Immanuel Medical Center	Omaha	Nebraska	United States	68122
314	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
315	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
316	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
317	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
318	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire	United States	03301
319	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire	United States	03833
320	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire	United States	03106
321	Lakes Region General Hospital	Laconia	New Hampshire	United States	03246
322	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire	United States	03103
323	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
324	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
325	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
326	Valley Hospital - Ridgewood	Ridgewood	New Jersey	United States	07450
327	Somerset Medical Center	Somerville	New Jersey	United States	08876
328	Overlook Hospital	Summit	New Jersey	United States	07902
329	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
330	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York	United States	11209
331	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
332	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
333	Adirondack Cancer Care - Glens Falls	Glens Falls	New York	United States	12801
334	Beth Israel Medical Center - Petrie Division	New York	New York	United States	10003-3803
335	NYU Cancer Institute at New York University Medical Center	New York	New York	United States	10016
336	St. Luke's - Roosevelt Hospital Center - St.Luke's Division	New York	New York	United States	10025
337	South Nassau Communities Hospital	Oceanside	New York	United States	11572
338	Unity Health System Cancer Care	Rochester	New York	United States	14611
339	Highland Hospital of Rochester	Rochester	New York	United States	14620
340	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
341	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
342	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
343	Faxton Regional Cancer Center	Utica	New York	United States	13502
344	Randolph Hospital	Asheboro	North Carolina	United States	27203-5400
345	John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital	Eden	North Carolina	United States	27288
346	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
347	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina	United States	27403-1198
348	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina	United States	27834
349	Annie Penn Cancer Center	Reidsville	North Carolina	United States	27320
350	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
351	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
352	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
353	MeritCare Broadway	Fargo	North Dakota	United States	58122
354	Trinity CancerCare Center	Minot	North Dakota	United States	58701
355	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
356	Mary Rutan Hospital	Bellefontaine	Ohio	United States	43311
357	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
358	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio	United States	44708
359	Aultman Cancer Center at Aultman Hospital	Canton	Ohio	United States	44710-1799
360	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
361	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
362	North Coast Cancer Care - Clyde	Clyde	Ohio	United States	43410
363	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210-1240
364	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
365	CCOP - Columbus	Columbus	Ohio	United States	43215
366	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
367	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
368	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
369	Grandview Hospital	Dayton	Ohio	United States	45405
370	Good Samaritan Hospital	Dayton	Ohio	United States	45406
371	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
372	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
373	CCOP - Dayton	Dayton	Ohio	United States	45429
374	Grady Memorial Hospital	Delaware	Ohio	United States	43015
375	Hematology Oncology Center	Elyria	Ohio	United States	44035
376	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
377	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
378	Wayne Hospital	Greenville	Ohio	United States	45331
379	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
380	Fairfield Medical Center	Lancaster	Ohio	United States	43130
381	St. Rita's Medical Center	Lima	Ohio	United States	45801
382	Lima Memorial Hospital	Lima	Ohio	United States	45804
383	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
384	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
385	St. Luke's Hospital	Maumee	Ohio	United States	43537
386	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
387	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
388	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
389	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
390	Mercy Medical Center	Springfield	Ohio	United States	45504
391	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
392	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
393	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
394	Toledo Hospital	Toledo	Ohio	United States	43606
395	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
396	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
397	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
398	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
399	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
400	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
401	Fulton County Health Center	Wauseon	Ohio	United States	43567
402	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
403	Clinton Memorial Hospital	Wilmington	Ohio	United States	45177
404	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Air Force Base	Ohio	United States	45433-5529
405	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
406	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
407	Bay Area Hospital	Coos Bay	Oregon	United States	97420
408	Kaiser Permanente Health Care - Portland	Portland	Oregon	United States	97232
409	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
410	St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	Pennsylvania	United States	18015
411	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
412	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
413	Mercy Fitzgerald Hospital	Darby	Pennsylvania	United States	19023
414	Geisinger Hazleton Cancer Center	Hazleton	Pennsylvania	United States	18201
415	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
416	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
417	Riddle Memorial Hospital Cancer Center	Media	Pennsylvania	United States	19063
418	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
419	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
420	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
421	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
422	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
423	Albert Einstein Cancer Center	Philadelphia	Pennsylvania	United States	19141
424	UPMC Cancer Centers	Pittsburgh	Pennsylvania	United States	15232
425	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania	United States	19464
426	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania	United States	18840
427	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
428	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
429	Jennersville Regional Hospital	West Grove	Pennsylvania	United States	19390-9499
430	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
431	Susquehanna Cancer Center at Divine Providence Hospital	Williamsport	Pennsylvania	United States	17701
432	CCOP - Main Line Health	Wynnewood	Pennsylvania	United States	19096
433	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
434	York Cancer Center at Apple Hill Medical Center	York	Pennsylvania	United States	17405
435	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island	United States	02903
436	Miriam Hospital	Providence	Rhode Island	United States	02906
437	AnMed Cancer Center	Anderson	South Carolina	United States	29621
438	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina	United States	29401
439	CCOP - Greenville	Greenville	South Carolina	United States	29615
440	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
441	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
442	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
443	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
444	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
445	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37662
446	U.T. Medical Center Cancer Institute	Knoxville	Tennessee	United States	37920-6999
447	University of Tennessee Cancer Institute - Memphis	Memphis	Tennessee	United States	38104
448	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee	United States	38104
449	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
450	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
451	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
452	Wilford Hall Medical Center	Lackland Air Force Base	Texas	United States	78236
453	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas	United States	79410-1894
454	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78209
455	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
456	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
457	University Hospital - San Antonio	San Antonio	Texas	United States	78229
458	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
459	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908
460	Danville Regional Medical Center	Danville	Virginia	United States	24541
461	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
462	Virginia Oncology Associates - Hampton	Hampton	Virginia	United States	23666
463	Southwest Virginia Regional Cancer Center at Wellmonth Health	Norton	Virginia	United States	24273
464	Auburn Regional Center for Cancer Care	Auburn	Washington	United States	98002
465	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
466	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
467	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
468	St. Francis Hospital	Federal Way	Washington	United States	98003
469	Columbia Basin Hematology	Kennewick	Washington	United States	99336
470	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
471	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
472	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
473	Harborview Medical Center	Seattle	Washington	United States	98104
474	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
475	Group Health Central Hospital	Seattle	Washington	United States	98112
476	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
477	Polyclinic First Hill	Seattle	Washington	United States	98122
478	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
479	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
480	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
481	Allenmore Hospital	Tacoma	Washington	United States	98405
482	CCOP - Northwest	Tacoma	Washington	United States	98405
483	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
484	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
485	St. Clare Hospital	Tacoma	Washington	United States	98499
486	Schiffler Cancer Center at Wheeling Hospital	Wheeling	West Virginia	United States	26003
487	Fox Valley Hematology and Oncology - East Grant Street	Appleton	Wisconsin	United States	54911-3496
488	Marshfield Clinic - Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
489	Center for Cancer Treatment & Prevention at Sacred Heart Hospital	Eau Claire	Wisconsin	United States	54701
490	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
491	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
492	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
493	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
494	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
495	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin	United States	54601
496	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin	United States	54601
497	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
498	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
499	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
500	Saint Joseph's Hospital	Marshfield	Wisconsin	United States	54449
501	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
502	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin	United States	53066
503	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
504	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin	United States	53405
505	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
506	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
507	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
508	Saint Michael's Hospital Cancer Center	Stevens Point	Wisconsin	United States	54481
509	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
510	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin	United States	53188
511	Marshfield Clinic - Wausau Center	Wausau	Wisconsin	United States	54401
512	Diagnostic and Treatment Center	Weston	Wisconsin	United States	54476
513	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
514	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
515	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801
516	Tom Baker Cancer Centre - Calgary	Calgary	Alberta	Canada	T2N 4N2
517	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
518	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
519	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
520	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
521	St. Joseph's Hospital - Charlton Campus	Hamilton	Ontario	Canada	L8N 4A6
522	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
523	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario	Canada	K7L 5P9
524	London Regional Cancer Program at London Health Sciences Centre	London	Ontario	Canada	N6A 4L6
525	Ottawa Hospital Regional Cancer Centre - General Campus	Ottawa	Ontario	Canada	K1H 8L6
526	Algoma District Cancer Program at Sault Area Hospital	Sault Ste. Marie	Ontario	Canada	P6A 2C4
527	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario	Canada	P3E 5J1
528	Cancer Care Program at Thunder Bay Regional Health Sciences	Thunder Bay	Ontario	Canada	P7B 6V4
529	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
530	Trillium Health Centre - Mississauga Site	Toronto	Ontario	Canada	M9C 1A5
531	Hopital Notre-Dame du CHUM	Montreal	Quebec	Canada	H2L 4M1
532	L'Hopital Laval	Quebec		Canada	G1V 4G5

Sponsors and Collaborators

• ECOG-ACRIN Cancer Research Group
• National Cancer Institute (NCI)
• Southwest Oncology Group
• North Central Cancer Treatment Group
• NCIC Clinical Trials Group
• Cancer and Leukemia Group B

Investigators

• Study Chair: Daniel D. Karp, MD, M.D. Anderson Cancer Center
• Study Chair: Omer Kucuk, MD, Barbara Ann Karmanos Cancer Institute
• Study Chair: Randolph S. Marks, MD, Mayo Clinic
• Study Chair: Michael R. Johnston, MD, FRCSC, Nova Scotia Cancer Centre
• Study Chair: Gerald H. Clamon, MD, Holden Comprehensive Cancer Center
• Study Chair: Gord Okawara, MD, Margaret and Charles Juravinski Cancer Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ECOG-ACRIN Cancer Research Group
• ClinicalTrials.gov Identifier: NCT00008385
• Other Study ID Numbers: E5597; E5597; U10CA023318; CDR0000068402
• First Posted: Jan 27, 2003
• Last Update Posted: Nov 17, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by ECOG-ACRIN Cancer Research Group: stage I non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Selenium

Study Results

Participant Flow

Recruitment Details	The study was activated on 10/6/2000 and terminated early on 11/5/2009 due to futility analysis with a total accrual of 1772 patients to step 1. Of the 1772 patients, 1561 were randomized on step 2.
Pre-assignment Detail	The study had a 4-week run-in period to select patients with good compliance with the protocol therapy, defined as consuming at least 75% of prescribed placebo tablets. These patients were then randomized.

Arm/Group Title	Arm I (Placebo)	Arm II (Selenium)
Arm/Group Description	Participants receive an oral yeast placebo as in arm II. placebo: Given orally	Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity. selenium: Given orally
Period Title: Overall Study
STARTED	521	1040
Treated	477	865
Off Treatment Reasons Reported	398	795
COMPLETED	134	238
NOT COMPLETED	387	802

Baseline Characteristics

Arm/Group Title	Arm I (Placebo)	Arm II (Selenium)	Total
Arm/Group Description	Participants receive an oral yeast placebo as in arm II. placebo: Given orally	Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity. selenium: Given orally	Total of all reporting groups
Overall Participants	521	1040	1561
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	66	66	66
Sex: Female, Male (Count of Participants)
Female	271 52%	531 51.1%	802 51.4%
Male	250 48%	509 48.9%	759 48.6%

Outcome Measures

1. Primary Outcome

Title	Incidence Rate of Second Primary Lung Tumor
Description	Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.
Time Frame	Assessed annually for 10 years after randomization

Outcome Measure Data

Analysis Population Description

all randomized patients

Arm/Group Title	Arm I (Placebo)	Arm II (Selenium)
Arm/Group Description	Participants receive an oral yeast placebo as in arm II. placebo: Given orally	Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity. selenium: Given orally
Measure Participants	521	1040
Number [cases/100 person years]	1.30	1.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Placebo), Arm II (Selenium)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.294
	Comments	This p value should be compared to the nominal p value of 0.0035 adjusting for the previous interim analyses
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95%; 0.64 to 2.37
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence interval was repeated confidence interval for the risk ratio

2. Secondary Outcome

Title	5-year Progression-free Survival Rate
Description	Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate. Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer. Different histologic type Location in different lobe Location in contralateral lung Occurrence > 5 years after initial diagnosis
Time Frame	Assessed annually for 5 years after randomization

Outcome Measure Data

Analysis Population Description

All randomized patients

Arm/Group Title	Arm I (Placebo)	Arm II (Selenium)
Arm/Group Description	Participants receive an oral yeast placebo as in arm II. placebo: Given orally	Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity. selenium: Given orally
Measure Participants	521	1040
Number (95% Confidence Interval) [proportion of participants]	0.796 0.2%	0.744 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Placebo), Arm II (Selenium)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.069
	Comments
	Method	Log Rank
	Comments

3. Secondary Outcome

Title	5-year Overall Survival Rate
Description	Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.
Time Frame	Assessed annually for 5 years after randomization

Outcome Measure Data

Analysis Population Description

All randomized patients

Arm/Group Title	Arm I (Placebo)	Arm II (Selenium)
Arm/Group Description	Participants receive an oral yeast placebo as in arm II. placebo: Given orally	Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity. selenium: Given orally
Measure Participants	521	1040
Number (95% Confidence Interval) [proportion of participants]	0.799 0.2%	0.768 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Placebo), Arm II (Selenium)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.154
	Comments
	Method	Log Rank
	Comments

Adverse Events

Time Frame	assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
Arm/Group Title	Arm I (Placebo)		Arm II (Selenium)
Arm/Group Description	Participants receive an oral yeast placebo as in arm II. placebo: Given orally		Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity. selenium: Given orally
All Cause Mortality
	Arm I (Placebo)		Arm II (Selenium)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I (Placebo)		Arm II (Selenium)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/477 (1.9%)		13/865 (1.5%)
Cardiac disorders
Cardiac-left ventricular function	0/477 (0%)		1/865 (0.1%)
Gastrointestinal disorders
Colitis	1/477 (0.2%)		0/865 (0%)
Nausea	0/477 (0%)		1/865 (0.1%)
Stomatitis	1/477 (0.2%)		0/865 (0%)
Vomiting	0/477 (0%)		1/865 (0.1%)
Diarrhea w/o prior colostomy	0/477 (0%)		2/865 (0.2%)
General disorders
Constitutional	1/477 (0.2%)		0/865 (0%)
Chest pain	0/477 (0%)		1/865 (0.1%)
Infections and infestations
Infection-other	1/477 (0.2%)		0/865 (0%)
Investigations
Neutrophils decreased	0/477 (0%)		1/865 (0.1%)
Creatinine increased	0/477 (0%)		1/865 (0.1%)
Metabolism and nutrition disorders
Anorexia	0/477 (0%)		1/865 (0.1%)
Dehydration	0/477 (0%)		1/865 (0.1%)
Hyperglycemia	1/477 (0.2%)		0/865 (0%)
Hyperkalemia	0/477 (0%)		2/865 (0.2%)
Hyponatremia	0/477 (0%)		1/865 (0.1%)
Musculoskeletal and connective tissue disorders
Myositis	0/477 (0%)		1/865 (0.1%)
Joint, muscle, bone-other	0/477 (0%)		1/865 (0.1%)
Nervous system disorders
Syncope	0/477 (0%)		1/865 (0.1%)
Psychiatric disorders
Depression	0/477 (0%)		1/865 (0.1%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/477 (0.2%)		1/865 (0.1%)
Pulmonary-other	0/477 (0%)		1/865 (0.1%)
Skin and subcutaneous tissue disorders
Rash/desquamation	2/477 (0.4%)		1/865 (0.1%)
Skin-other	1/477 (0.2%)		0/865 (0%)
Vascular disorders
Hypotension	0/477 (0%)		1/865 (0.1%)
Thrombosis/embolism	0/477 (0%)		1/865 (0.1%)
Other (Not Including Serious) Adverse Events
	Arm I (Placebo)		Arm II (Selenium)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/477 (11.5%)		99/865 (11.4%)
General disorders
Fatigue	32/477 (6.7%)		64/865 (7.4%)
Skin and subcutaneous tissue disorders
Nail changes	34/477 (7.1%)		46/865 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.