Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer
Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer
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.
OBJECTIVES:
Primary Objective:
Secondary Objectives:
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.
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.
RUN-IN PERIOD:
Inclusion Criteria:
Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small lung cancer (except carcinoid)*
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:
STUDY PHASE:
Scottsdale, Arizona 85251, United States
Scottsdale, Arizona 85260, United States
Little Rock, Arkansas 72205, United States
Los Angeles, California 90048, United States
Marysville, California 95901, United States
Pomona, California 91767, United States
Rancho Mirage, California 92270, United States
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06102-5037, United States
Pensacola, Florida 32514, United States
Savannah, Georgia 31405, United States
Valdosta, Georgia 31603, United States
Boise, Idaho 83706, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Maywood, Illinois 60153, United States
Moline, Illinois 61265, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Indianapolis, Indiana 46202-5289, United States
La Porte, Indiana 46350, United States
Wichita, Kansas 67214, United States
Madisonville, Kentucky 42431, United States
Owensboro, Kentucky 42303, United States
Baltimore, Maryland 21231-2410, United States
Springfield, Massachusetts 01199, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Concord, New Hampshire 03301, United States
Morristown, New Jersey 07962, United States
New Brunswick, New Jersey 08903, United States
Voorhees Township, New Jersey 08043, United States
East Syracuse, New York 13057, United States
Rochester, New York 14642, United States
Eden, North Carolina 27288, United States
Greensboro, North Carolina 27403-1198, United States
Winston-Salem, North Carolina 27157-1096, United States
Columbus, Ohio 43210-1240, United States
Wright-Patterson Air Force Base, Ohio 45433-5529, United States
Allentown, Pennsylvania 18105, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19104-4283, United States
Philadelphia, Pennsylvania 19107-5541, United States
Wilkes-Barre, Pennsylvania 18711, United States
Williamsport, Pennsylvania 17701, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Kingsport, Tennessee 37662, United States
Dallas, Texas 75390, United States
San Antonio, Texas 78229-3900, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195-6043, United States
Eau Claire, Wisconsin 54701, United States
Green Bay, Wisconsin 54301-3526, United States
Madison, Wisconsin 53792-6164, United States
Kelowna, British Columbia V1Y 5L3, Canada