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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00032084 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: bupropion hydrochloride Drug: nicotine Procedure: psychosocial assessment and care Procedure: smoking cessation intervention |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control |
Official Title: | 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 |
Study Start Date: | January 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage I or II non-small cell lung cancer with complete resection of all disease
Current smoker defined as:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Ellen R. Gritz, PhD | M.D. Anderson Cancer Center |
Study Chair: | Philip C. Hoffman, MD | University of Chicago |
Study Chair: | James Stevenson, MD | Presbyterian Medical Center |
Study ID Numbers: | CDR0000069256, SWOG-S0002, CALGB-79807, ECOG-S0002, NCI-P02-0215 |
Study First Received: | March 8, 2002 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00032084 |
Health Authority: | United States: Federal Government |
non-small cell lung cancer stage I non-small cell lung cancer stage II non-small cell lung cancer |
Thoracic Neoplasms Nicotine polacrilex Non-small cell lung cancer Carcinoma Smoking Dopamine Respiratory Tract Diseases |
Lung Neoplasms Nicotine Lung Diseases Bupropion Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Dopamine Uptake Inhibitors Respiratory Tract Neoplasms Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |