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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

placebo

selenium

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring stage I non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

MBCCOP - Gulf Coast
Providence Cancer Center at Providence Hospital
Arizona Oncology Services Foundation
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
Mayo Clinic Scottsdale
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Highlands Oncology Group - Springdale
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
East Bay Radiation Oncology Center
Eden Medical Center
North Bay Cancer Center
Rebecca and John Moores UCSD Cancer Center
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Contra Costa Regional Medical Center
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Memorial Medical Center
El Camino Hospital Cancer Center
Highland General Hospital
Alta Bates Summit Medical Center - Summit Campus
Bay Area Breast Surgeons, Incorporated
CCOP - Bay Area Tumor Institute
Larry G Strieff MD Medical Corporation
Tom K Lee, Incorporated
Veterans Affairs Medical Center - Palo Alto
Valley Care Medical Center
Valley Medical Oncology Consultants - Pleasanton
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
University of California Davis Cancer Center
Mercy General Hospital
Kaiser Permanente Medical Office -Vandever Medical Office
Doctors Medical Center - San Pablo Campus
Stanford Cancer Center
Tahoe Forest Cancer Center
Aurora Presbyterian Hospital
Boulder Community Hospital
Penrose Cancer Center at Penrose Hospital
St. Anthony Central Hospital
Porter Adventist Hospital
Presbyterian - St. Luke's Medical Center
St. Joseph Hospital
Rose Medical Center
CCOP - Colorado Cancer Research Program
Swedish Medical Center
Poudre Valley Hospital
Front Range Cancer Specialists
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
North Colorado Medical Center
Sky Ridge Medical Center
Hope Cancer Care Center at Longmont United Hospital
McKee Medical Center
St. Mary - Corwin Regional Medical Center
North Suburban Medical Center
Exempla Lutheran Medical Center
Praxair Cancer Center at Danbury Hospital
Helen and Harry Gray Cancer Center at Hartford Hospital
Hospital of Saint Raphael
Eastern Connecticut Hematology and Oncology Associates
Connecticut Oncology & Hematology - Torrington
Tunnell Cancer Center at Beebe Medical Center
CCOP - Christiana Care Health Services
Walter Reed Army Medical Center
Mayo Clinic - Jacksonville
Sacred Heart Cancer Center at Sacred Heart Hospital
West Florida Cancer Institute at West Florida Hospital - Pensacola
Piedmont Hospital
Winship Cancer Institute of Emory University
Northside Hospital Cancer Center
Saint Joseph's Hospital of Atlanta
CCOP - Atlanta Regional
WellStar Cobb Hospital
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Veterans Affairs Medical Center - Atlanta (Decatur)
Gwinnett Medical Center
Kennestone Cancer Center at Wellstar Kennestone Hospital
Southern Regional Medical Center
Harbin Clinic Cancer Center - Medical Oncology
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Kapiolani Medical Center at Pali Momi
Cancer Research Center of Hawaii
OnCare Hawaii, Incorporated - Lusitana
Queen's Cancer Institute at Queen's Medical Center
Straub Clinic and Hospital, Incorporated
Hawaii Medical Center - East
OnCare Hawaii, Incorporated - Kuakini
Kapiolani Medical Center for Women and Children
Tripler Army Medical Center
Maui Memorial Medical Center
Pacific Cancer Institute - Maui
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Hematology Oncology Associates of Illinois - Berwyn
Illinois CancerCare - Bloomington
St. Joseph Medical Center
Graham Hospital
Illinois CancerCare - Canton
Illinois CancerCare - Carthage
Memorial Hospital
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Hematology and Oncology Associates
John H. Stroger, Jr. Hospital of Cook County
University of Illinois Cancer Center
Veterans Affairs Medical Center - Chicago Westside Hospital
Saint Joseph Hospital
Decatur Memorial Hospital Cancer Care Institute
Sherman Hospital
Alexian Brothers Radiation Oncology
Elmhurst Memorial Hospital
Eureka Community Hospital
Illinois CancerCare - Eureka
Evanston Hospital
Galesburg Clinic, PC
Galesburg Cottage Hospital
Illinois CancerCare - Galesburg
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Illinois CancerCare - Havana
Mason District Hospital
Midwest Center for Hematology/Oncology
Joliet Oncology-Hematology Associates, Limited - West
Illinois CancerCare - Kewanee Clinic
North Shore Oncology and Hematology Associates, Limited - Libertyville
Illinois CancerCare - Macomb
McDonough District Hospital
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Illinois CancerCare - Monmouth
OSF Holy Family Medical Center
La Grange Oncology Associates - Geneva
Cancer Care and Hematology Specialists of Chicagoland - Niles
BroMenn Regional Medical Center
Community Cancer Center
Illinois CancerCare - Community Cancer Center
Community Hospital of Ottawa
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Cancer Treatment Center at Pekin Hospital
Illinois CancerCare - Pekin
Proctor Hospital
CCOP - Illinois Oncology Research Association
Oncology Hematology Associates of Central Illinois, PC - Peoria
Methodist Medical Center of Illinois
OSF St. Francis Medical Center
Illinois CancerCare - Peru
Illinois Valley Community Hospital
Illinois CancerCare - Princeton
Swedish-American Regional Cancer Center
Hematology Oncology Associates - Skokie
Illinois CancerCare - Spring Valley
St. Margaret's Hospital
Regional Cancer Center at Memorial Medical Center
St. Francis Hospital and Health Centers - Beech Grove Campus
Elkhart General Hospital
Indiana University Melvin and Bren Simon Cancer Center
Veterans Affairs Medical Center - Indianapolis
William N. Wishard Memorial Hospital
Howard Community Hospital
Center for Cancer Therapy at LaPorte Hospital and Health Services
Reid Hospital & Health Care Services
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
Saint Joseph Regional Medical Center
South Bend Clinic
McFarland Clinic, PC
Iowa Blood and Cancer Care
St. Luke's Hospital
Cedar Rapids Oncology Associates
Mercy Regional Cancer Center at Mercy Medical Center
Genesis Regional Cancer Center at Genesis Medical Center
Mercy Cancer Center at Mercy Medical Center - North Iowa
McCreery Cancer Center at Ottumwa Regional
Siouxland Hematology-Oncology Associates, LLP
Mercy Medical Center - Sioux City
St. Luke's Regional Medical Center
Hospital District Sixth of Harper County
Cancer Center of Kansas, PA - Chanute
Cancer Center of Kansas, PA - Dodge City
Cancer Center of Kansas, PA - El Dorado
Cancer Center of Kansas - Fort Scott
Cancer Center of Kansas-Independence
Cancer Center of Kansas, PA - Kingman
Lawrence Memorial Hospital
Southwest Medical Center
Cancer Center of Kansas, PA - Newton
Menorah Medical Center
Cancer Center of Kansas, PA - Parsons
Cancer Center of Kansas, PA - Pratt
Cancer Center of Kansas, PA - Salina
Tammy Walker Cancer Center at Salina Regional Health Center
Shawnee Mission Medical Center
Cotton-O'Neil Cancer Center
Cancer Center of Kansas, PA - Wellington
Associates in Womens Health, PA - North Review
Cancer Center of Kansas, PA - Medical Arts Tower
Cancer Center of Kansas, PA - Wichita
CCOP - Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center
Cancer Center of Kansas, PA - Winfield
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Mitchell Memorial Cancer Center at Owensboro Medical Health System
Tulane Cancer Center Office of Clinical Research
Ochsner Health Center - Bluebonnet
CCOP - Ochsner
Ochsner Cancer Institute at Ochsner Clinic Foundation
York Hospital's Oncology Treatment Center
Greater Baltimore Medical Center Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Union Hospital Cancer Program at Union Hospital
Boston University Cancer Research Center
Caritas St. Elizabeth's Medical Center
Cape Cod Hospital
Caritas Norwood Hospital
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Hickman Cancer Center at Bixby Medical Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
University of Michigan Comprehensive Cancer Center
Battle Creek Health System Cancer Care Center
Mecosta County Medical Center
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Barbara Ann Karmanos Cancer Institute
Green Bay Oncology, Limited - Escanaba
Genesys Hurley Cancer Institute
Hurley Medical Center
Butterworth Hospital at Spectrum Health
CCOP - Grand Rapids
Lacks Cancer Center at Saint Mary's Health Care
Van Elslander Cancer Center at St. John Hospital and Medical Center
Dickinson County Healthcare System
Foote Memorial Hospital
Borgess Medical Center
West Michigan Cancer Center
Bronson Methodist Hospital
Haematology-Oncology Associates of Ohio and Michigan, PC
Breslin Cancer Center at Ingham Regional Medical Center
Sparrow Regional Cancer Center
St. Mary Mercy Hospital
Community Cancer Center of Monroe
Mercy Memorial Hospital - Monroe
Mercy General Health Partners
St. Joseph Mercy Oakland
Mercy Regional Cancer Center at Mercy Hospital
William Beaumont Hospital - Royal Oak Campus
Seton Cancer Institute at Saint Mary's - Saginaw
Lakeland Regional Cancer Care Center - St. Joseph
Munson Medical Center
St. John Macomb Hospital
Metro Health Hospital
MeritCare Bemidji
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
Duluth Clinic Cancer Center - Duluth
CCOP - Duluth
Miller - Dwan Medical Center
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Hutchinson Area Health Care
HealthEast Cancer Care at St. John's Hospital
Minnesota Oncology Hematology, PA - Maplewood
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Hennepin County Medical Center - Minneapolis
Veterans Affairs Medical Center - Minneapolis
Masonic Cancer Center at University of Minnesota
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Mayo Clinic Cancer Center
CentraCare Clinic - River Campus
Coborn Cancer Center
CCOP - Metro-Minnesota
Park Nicollet Cancer Center
Regions Hospital Cancer Care Center
United Hospital
St. Francis Cancer Center at St. Francis Medical Center
Ridgeview Medical Center
Willmar Cancer Center at Rice Memorial Hospital
Minnesota Oncology Hematology, PA - Woodbury
Hattiesburg Clinic, PA at Forrest General
Truman Medical Center - Hospital Hill
Saint Luke's Cancer Institute at Saint Luke's Hospital
St. Joseph Medical Center
North Kansas City Hospital
CCOP - Kansas City
Research Medical Center
Liberty Hospital
Heartland Regional Medical Center
Christian Hospital Northeast Cancer Care Center
CCOP - Cancer Research for the Ozarks
St. John's Regional Health Center
CCOP - Montana Cancer Consortium
Hematology-Oncology Centers of the Northern Rockies - Billings
Northern Rockies Radiation Oncology Center
St. Vincent Healthcare Cancer Care Services
Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
St. James Healthcare Cancer Care
Big Sky Oncology
Great Falls Clinic - Main Facility
Sletten Cancer Institute at Benefis Healthcare
Northern Montana Hospital
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Medical Oncology at KRMC
Kalispell Regional Medical Center
Community Medical Center
Guardian Oncology and Center for Wellness
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Good Samaritan Cancer Center at Good Samaritan Hospital
Cancer Resource Center - Lincoln
CCOP - Missouri Valley Cancer Consortium
Methodist Estabrook Cancer Center
Immanuel Medical Center
Alegant Health Cancer Center at Bergan Mercy Medical Center
Creighton University Medical Center
University Medical Center of Southern Nevada
CCOP - Nevada Cancer Research Foundation
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Center for Cancer Care at Exeter Hospital
New Hampshire Oncology - Hematology, PA - Hooksett
Lakes Region General Hospital
Elliot Regional Cancer Center at Elliot Hospital
Cancer Institute of New Jersey at Hamilton
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Valley Hospital - Ridgewood
Somerset Medical Center
Overlook Hospital
Cancer Institute of New Jersey at Cooper - Voorhees
Veterans Affairs Medical Center - Brooklyn
Roswell Park Cancer Institute
CCOP - Hematology-Oncology Associates of Central New York
Adirondack Cancer Care - Glens Falls
Beth Israel Medical Center - Petrie Division
NYU Cancer Institute at New York University Medical Center
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
South Nassau Communities Hospital
Unity Health System Cancer Care
Highland Hospital of Rochester
James P. Wilmot Cancer Center at University of Rochester Medical Center
SUNY Upstate Medical University Hospital
Veterans Affairs Medical Center - Syracuse
Faxton Regional Cancer Center
Randolph Hospital
John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital
Wayne Memorial Hospital, Incorporated
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Leo W. Jenkins Cancer Center at ECU Medical School
Annie Penn Cancer Center
Rutherford Hospital
Wake Forest University Comprehensive Cancer Center
CCOP - MeritCare Hospital
MeritCare Broadway
Trinity CancerCare Center
McDowell Cancer Center at Akron General Medical Center
Mary Rutan Hospital
Wood County Oncology Center
Mercy Cancer Center at Mercy Medical Center
Aultman Cancer Center at Aultman Hospital
Adena Regional Medical Center
Charles M. Barrett Cancer Center at University Hospital
North Coast Cancer Care - Clyde
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Medical Center Cancer Care
Mount Carmel Health - West Hospital
Doctors Hospital at Ohio Health
Grandview Hospital
Good Samaritan Hospital
David L. Rike Cancer Center at Miami Valley Hospital
Samaritan North Cancer Care Center
CCOP - Dayton
Grady Memorial Hospital
Hematology Oncology Center
Blanchard Valley Medical Associates
Middletown Regional Hospital
Wayne Hospital
Charles F. Kettering Memorial Hospital
Fairfield Medical Center
St. Rita's Medical Center
Lima Memorial Hospital
Strecker Cancer Center at Marietta Memorial Hospital
Northwest Ohio Oncology Center
St. Luke's Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
St. Charles Mercy Hospital
Toledo Clinic - Oregon
North Coast Cancer Care, Incorporated
Mercy Medical Center
Community Hospital of Springfield and Clark County
Flower Hospital Cancer Center
Mercy Hospital of Tiffin
Toledo Hospital
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
St. Anne Mercy Hospital
Toledo Clinic, Incorporated - Main Clinic
UVMC Cancer Care Center at Upper Valley Medical Center
Fulton County Health Center
Mount Carmel St. Ann's Cancer Center
Clinton Memorial Hospital
United States Air Force Medical Center - Wright-Patterson
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Genesis - Good Samaritan Hospital
Bay Area Hospital
Kaiser Permanente Health Care - Portland
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
St. Luke's Cancer Network at St. Luke's Hospital
Bryn Mawr Hospital
Geisinger Cancer Institute at Geisinger Health
Mercy Fitzgerald Hospital
Geisinger Hazleton Cancer Center
Penn State Cancer Institute at Milton S. Hershey Medical Center
Lewistown Hospital
Riddle Memorial Hospital Cancer Center
Cancer Center of Paoli Memorial Hospital
Abramson Cancer Center of the University of Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Joan Karnell Cancer Center at Pennsylvania Hospital
Fox Chase Cancer Center - Philadelphia
Albert Einstein Cancer Center
UPMC Cancer Centers
Pottstown Memorial Regional Cancer Center
Guthrie Cancer Center at Guthrie Clinic Sayre
Geisinger Medical Group - Scenery Park
Mount Nittany Medical Center
Jennersville Regional Hospital
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Susquehanna Cancer Center at Divine Providence Hospital
CCOP - Main Line Health
Lankenau Cancer Center at Lankenau Hospital
York Cancer Center at Apple Hill Medical Center
Rhode Island Hospital Comprehensive Cancer Center
Miriam Hospital
AnMed Cancer Center
Roper St. Francis Cancer Center at Roper Hospital
CCOP - Greenville
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Avera Cancer Institute
Medical X-Ray Center, PC
Sanford Cancer Center at Sanford USD Medical Center
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
U.T. Medical Center Cancer Institute
University of Tennessee Cancer Institute - Memphis
Veterans Affairs Medical Center - Memphis
Vanderbilt-Ingram Cancer Center
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Brooke Army Medical Center
Wilford Hall Medical Center
Joe Arrington Cancer Research and Treatment Center
Veterans Affairs Medical Center - San Antonio (Murphy)
University of Texas Health Science Center at San Antonio
Cancer Therapy and Research Center
University Hospital - San Antonio
Huntsman Cancer Institute at University of Utah
University of Virginia Cancer Center
Danville Regional Medical Center
Fredericksburg Oncology, Incorporated
Virginia Oncology Associates - Hampton
Southwest Virginia Regional Cancer Center at Wellmonth Health
Auburn Regional Center for Cancer Care
St. Joseph Cancer Center
Olympic Hematology and Oncology
Providence Centralia Hospital
St. Francis Hospital
Columbia Basin Hematology
Providence St. Peter Hospital Regional Cancer Center
Good Samaritan Cancer Center
Fred Hutchinson Cancer Research Center
Harborview Medical Center
Minor and James Medical, PLLC
Group Health Central Hospital
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Polyclinic First Hill
University Cancer Center at University of Washington Medical Center
Cancer Care Northwest - Spokane South
Franciscan Cancer Center at St. Joseph Medical Center
Allenmore Hospital
CCOP - Northwest
MultiCare Regional Cancer Center at Tacoma General Hospital
Madigan Army Medical Center - Tacoma
St. Clare Hospital
Schiffler Cancer Center at Wheeling Hospital
Fox Valley Hematology and Oncology - East Grant Street
Marshfield Clinic - Chippewa Center
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Marshfield Clinic Cancer Care at Regional Cancer Center
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay Oncology, Limited at St. Mary's Hospital
St. Mary's Hospital Medical Center - Green Bay
St. Vincent Hospital Regional Cancer Center
Franciscan Skemp Healthcare - La Crosse Campus
Gundersen Lutheran Center for Cancer and Blood
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Bay Area Cancer Care Center at Bay Area Medical Center
Marshfield Clinic - Marshfield Center
Saint Joseph's Hospital
Marshfield Clinic - Lakeland Center
Regional Cancer Center at Oconomowoc Memorial Hospital
Green Bay Oncology, Limited - Oconto Falls
All Saints Cancer Center at Wheaton Franciscan Healthcare
Ministry Medical Group at Saint Mary's Hospital
Marshfield Clinic - Indianhead Center
Marshfield Clinic at Saint Michael's Hospital
Saint Michael's Hospital Cancer Center
Green Bay Oncology, Limited - Sturgeon Bay
Waukesha Memorial Hospital Regional Cancer Center
Marshfield Clinic - Wausau Center
Diagnostic and Treatment Center
Marshfield Clinic - Weston Center
Marshfield Clinic - Wisconsin Rapids Center
Welch Cancer Center at Sheridan Memorial Hospital
Tom Baker Cancer Centre - Calgary
British Columbia Cancer Agency - Centre for the Southern Interior
CancerCare Manitoba
Saint John Regional Hospital
Nova Scotia Cancer Centre
St. Joseph's Hospital - Charlton Campus
Margaret and Charles Juravinski Cancer Centre
Cancer Centre of Southeastern Ontario at Kingston General Hospital
London Regional Cancer Program at London Health Sciences Centre
Ottawa Hospital Regional Cancer Centre - General Campus
Algoma District Cancer Program at Sault Area Hospital
Northeastern Ontario Regional Cancer Centre
Cancer Care Program at Thunder Bay Regional Health Sciences
Princess Margaret Hospital
Trillium Health Centre - Mississauga Site
Hopital Notre-Dame du CHUM
L'Hopital Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

Participants receive an oral yeast placebo as in 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.

Outcomes

Primary Outcome Measures

Incidence Rate of Second Primary Lung Tumor

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

5-year Progression-free Survival Rate

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

5-year Overall Survival Rate

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.

Full Information

NCT ID

NCT00008385

First Posted

January 6, 2001

Last Updated

June 20, 2023

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI), SWOG Cancer Research Network, North Central Cancer Treatment Group, NCIC Clinical Trials Group, Cancer and Leukemia Group B

1. Study Identification

Unique Protocol Identification Number

NCT00008385

Brief Title

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

Official Title

Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 18, 2000 (Actual)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI), SWOG Cancer Research Network, North Central Cancer Treatment Group, NCIC Clinical Trials Group, Cancer and Leukemia Group B

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

stage I non-small cell lung cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1772 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Placebo Comparator

Arm Description

Participants receive an oral yeast placebo as in arm II.

Arm Title

Arm II

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Given orally

Intervention Type

Drug

Intervention Name(s)

selenium

Other Intervention Name(s)

L-selenomethionine

Intervention Description

Given orally

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

Title

5-year Progression-free Survival Rate

Description

Time Frame

Assessed annually for 5 years after randomization

Title

5-year Overall Survival Rate

Description

Time Frame

Assessed annually for 5 years after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: