Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Active 18 and over NCI ECOG-5597 CAN-NCIC-BR16, CALGB-79803, NCCTG-E5597, SWOG-E5597, NCI-P00-0176, NCT00008385, BR16

Special Category: NCI Web site featured trial

Objectives

1. 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.
2. Evaluate the qualitative and quantitative toxicity of selenium in these patients.
3. Compare the incidence of specific cancers, mortality from cancer, and overall survival of participants treated with selenium vs those treated with placebo.

Entry Criteria

Disease Characteristics:

• 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: *SWOG and 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]




• No evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks



• No synchronous lung or non-lung lesions or metastasis, even if resectable



• No history of more than one primary lung cancer at any time

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior or concurrent chemotherapy for recurrent lung cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior or concurrent radiotherapy for recurrent lung cancer

Surgery:

• See Disease Characteristics
• No concurrent surgery

Other:

• Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
• No concurrent supplement(s) containing more than 50 micrograms of selenium
• Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

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

Renal:

• Not specified

Other:

• No concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer

Expected Enrollment

A total of 1,960 participants (980 per arm) will be accrued for this study within 4 years.

Outcomes

Incidence second of primary lung tumors
Toxicity
Incidence of specific cancers, mortality from cancer, and overall survival

Outline

This is a randomized, double-blind, 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) and gender. Participants are randomized to one of two arms.

• Arm I: 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.



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

Participants are followed annually.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Daniel Karp, MD, Protocol chair		Ph: 713-745-7398; 800-392-1611

Southwest Oncology Group

Omer Kucuk, MD, Protocol chair		Ph: 313-576-8739; 800-527-6266 Email: kucuko@karmanos.org

North Central Cancer Treatment Group

Randolph Marks, MD, Protocol chair		Ph: 507-284-2511

NCIC-Clinical Trials Group

Michael Johnston, MD, FRCSC, Protocol chair		Ph: 902-473-6000 Email: michael.johnston@cdha.nshealth.ca

Cancer and Leukemia Group B

Gerald Clamon, MD, Protocol chair		Ph: 319-356-1932

U.S.A.
Arizona
	Phoenix
	Arizona Oncology Services Foundation
		Farley Yang, MD	Ph:  602-274-4484
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
		Clinical Trials Office - Virginia G. Piper Cancer Center	Ph:  480-323-1255
	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
		Farley Yang, MD	Ph:  602-274-4484
Arkansas
	Bentonville
	Highlands Oncology Group - Springdale
		Joseph Beck, MD, FACP	Ph:  479-751-2100
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Castro Valley
	East Bay Radiation Oncology Center
		James Feusner, MD	Ph:  510-428-3689
	Eden Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Castro Valley
		James Feusner, MD	Ph:  510-428-3689
	Fairfield
	North Bay Cancer Center
		Clinical Trials Office - North Bay Cancer Center	Ph:  707-429-6976
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	Glendale
	Glendale Memorial Hospital Comprehensive Cancer Center
		Clinical Trials Office - Glendale Memorial Hospital Comprehensive Cancer Center	Ph:  818-409-7653
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Los Angeles
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Robert McKenna, MD	Ph:  310-423-3277
	Marysville
	Tibotec Therapeutics - Division of Ortho Biotech Products, LP
		David Gandara, MD	Ph:  908-541-4500
	Modesto
	Memorial Medical Center
		Clinical Trials Office - Memorial Medical Center	Ph:  209-572-7116
	Oakland
	Alta Bates Summit Medical Center - Summit Campus
		Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus	Ph:  510-204-1414
	Bay Area Breast Surgeons, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	CCOP - Bay Area Tumor Institute
		James Feusner, MD	Ph:  510-428-3689
	Highland General Hospital
		James Feusner, MD	Ph:  510-428-3689
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Palo Alto
	Veterans Affairs Medical Center - Palo Alto
		Harlan Pinto, MD	Ph:  650-725-9057
	Pleasanton
	Valley Care Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Pleasanton
		James Feusner, MD	Ph:  510-428-3689
	Pomona
	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
		Clinical Trials Office - Robert and Beverly Lewis Family Cancer Care Center	Ph:  909-865-9555
	Rancho Mirage
	Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
		Davood Vafai, MD	Ph:  760-674-3600
	Sacramento
	Mercy General Hospital
		Colin Spears, MD	Ph:  916-736-1536
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	San Diego
	Kaiser Permanente Medical Office -Vandever Medical Office
		Han Koh	Ph:  619-528-2596
	Veterans Affairs Medical Center - San Diego
		Ajay Sandhu	Ph:  858-552-8585
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	San Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
	Truckee
	Tahoe Forest Cancer Center
		David Gandara, MD	Ph:  530-582-6450
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-2866
Colorado
	Aurora
	Aurora Presbyterian Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph:  303-938-5253
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo Pajon, MD	Ph:  303-777-2663
	Porter Adventist Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
	Rose Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	St. Anthony Central Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	St. Joseph Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Englewood
	Swedish Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Grand Junction
	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Greeley
	North Colorado Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Lone Tree
	Sky Ridge Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo Pajon, MD	Ph:  303-777-2663
	Loveland
	McKee Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Thornton
	North Suburban Medical Center
		Eduardo Pajon, MD	Ph:  303-777-2663
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph:  303-403-3605
Connecticut
	Danbury
	Praxair Cancer Center at Danbury Hospital
		Robert Cooper, MD	Ph:  203-792-5303
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
	New Haven
	Hospital of Saint Raphael
		Clinical Trials Office - Hospital of Saint Raphael	Ph:  203-789-3545
	Norwich
	Eastern Connecticut Hematology and Oncology Associates
		Dennis Slater, MD	Ph:  860-886-8362
	Torrington
	Connecticut Oncology & Hematology - Torrington
		Michael Magnifico, MD	Ph:  860-482-5384
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
District of Columbia
	Washington
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Florida
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Hollywood
	Memorial Cancer Institute at Memorial Regional Hospital
		Clinical Trials Office - Memorial Cancer Institute	Ph:  954-985-3443
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Tallahassee
	Tallahassee Memorial Hospital
		Timothy Bolek, MD	Ph:  850-431-5255
Georgia
	Altanta
	Winship Cancer Institute of Emory University
		Fadlo Khuri	Ph:  404-778-5180 888-946-7447
	Atlanta
	CCOP - Atlanta Regional
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Northside Hospital Cancer Center
		Clinical Trials Office - Northside Hospital Cancer Center	Ph:  404-303-3355
	Piedmont Hospital
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Saint Joseph's Hospital of Atlanta
		Clinical Trials Office - Saint Joseph's Hospital of Atlanta	Ph:  404-851-7115
	Austell
	WellStar Cobb Hospital
		Clinical Trials Office - WellStar Cobb Hospital	Ph:  770-793-5980
	Decatur
	Charles B. Eberhart Cancer Center at DeKalb Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Veterans Affairs Medical Center - Atlanta (Decatur)
		Fadlo Khuri	Ph:  404-728-7680
	Lawrenceville
	Gwinnett Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Marietta
	Kennestone Cancer Center at Wellstar Kennestone Hospital
		Clinical Trials Office - Kennestone Cancer Center	Ph:  770-793-5980
	Riverdale
	Southern Regional Medical Center
		Clinical Trials Office - Southern Regional Medical Center	Ph:  770-991-8611
	Savannah
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		Mark Taylor, MD	Ph:  912-819-6194voicemail
	Valdosta
	Pearlman Comprehensive Cancer Center at South Georgia Medical Center
		Jeffrey Hoy, MD	Ph:  229-259-4616
Hawaii
	Aiea
	Kapiolani Medical Center at Pali Momi
		Jonathan Cho	Ph:  808-486-6000
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph:  808-586-2979
	Hawaii Medical Center - East
		Jonathan Cho	Ph:  808-547-6011
	Kapiolani Medical Center for Women and Children
		Jonathan Cho	Ph:  808-973-8511
	OnCare Hawaii, Incorporated - Kuakini
		Jonathan Cho	Ph:  808-531-8521
	OnCare Hawaii, Incorporated - Lusitana
		Jonathan Cho	Ph:  808-524-6115
	Queen's Cancer Institute at Queen's Medical Center
		Jonathan Cho	Ph:  808-545-8778 800-547-4742
	Straub Clinic and Hospital, Incorporated
		Jonathan Cho