Smoking Cessation Intervention (Including Bupropion-Zyban Versus Placebo) for Completely Resected Stage I and II Non-Small Cell Lung Cancer Survivors Who Are Current Smokers
Smoking Cessation Intervention (Including Bupropion-Zyban Versus Placebo) for Completely Resected Stage I and II Non-Small Cell Lung Cancer Survivors Who Are Current Smokers
RATIONALE: A program that includes bupropion may be more effective in helping early-stage lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is more effective with or without bupropion.
PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit smoking with or without bupropion in treating patients who have undergone surgery for stage I or stage II non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to gender, prior neoadjuvant or concurrent adjuvant chemotherapy and/or radiotherapy (yes vs no), and time since prior surgery (less than 6 months vs 6 to 12 months vs more than 12 months). Patients are randomized to 1 of 2 arms.
All patients receive behavioral intervention comprising smoking cessation advice and education on day 1. Patients quit smoking on day 8. Patients then receive a nicotine transdermal patch once daily on days 8-77.
PROJECTED ACCRUAL: A total of 468 patients (234 [117 men and 117 women] per arm) will be accrued for this study within 3 years.
DISEASE CHARACTERISTICS:
Diagnosis of stage I or II non-small cell lung cancer with complete resection of all disease
Current smoker defined as:
Must establish a quit date that falls within 30 days after registration, but 7 days after physician advice and start of bupropion or placebo therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Tucson, Arizona 85724, United States
Los Angeles, California 90033-0804, United States
Los Angeles, California 90048, United States
Orange, California 92868, United States
Denver, Colorado 80010, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20422, United States
Hines, Illinois 60141, United States
Fort Wayne, Indiana 46885-5099, United States
Kansas City, Kansas 66160-7353, United States
Lexington, Kentucky 40536-0084, United States
Shreveport, Louisiana 71130-3932, United States
Baltimore, Maryland 21201, United States
Boston, Massachusetts 02115, United States
Worcester, Massachusetts 01655, United States
Columbia, Missouri 65203, United States
Lebanon, New Hampshire 03756-0002, United States
New York, New York 10032, United States
Rochester, New York 14642, United States
Syracuse, New York 13217, United States
Winston-Salem, North Carolina 27157-1082, United States
Charleston, South Carolina 29425, United States
San Antonio, Texas 78229-3900, United States
White River Junction, Vermont 05009, United States
Roanoke, Virginia 24014, United States