Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032084
Status:
TERMINATED
Last Update Posted:
2013-03-11
First Post:
2002-03-08
Brief Title:
S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was closed early due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Compare the effect of a smoking cessation intervention comprising behavior intervention and nicotine replacement with or without bupropion on 12-month quit rates in patients with completely resected stage I or II non-small cell lung cancer who are current smokers
Compare the predictors of smoking cessation success in patients treated with these regimens
Determine the relationship between smoking cessation and standard outcome measures eg second malignancies survival and symptom status in patients treated with these regimens
Compare the effect of these treatment regimens on emotional functioning in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to gender prior neoadjuvant or concurrent adjuvant chemotherapy andor 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
Arm I Patients receive oral bupropion once daily on days 1-3 and twice daily on days 4-77
Arm II Patients receive oral placebo as in arm I Patients are followed at 3 6 and 12 months and then annually for 10 years
PROJECTED ACCRUAL A total of 468 patients 234 117 men and 117 women per arm will be accrued for this study within 3 years
Compare the effect of a smoking cessation intervention comprising behavior intervention and nicotine replacement with or without bupropion on 12-month quit rates in patients with completely resected stage I or II non-small cell lung cancer who are current smokers
Compare the predictors of smoking cessation success in patients treated with these regimens
Determine the relationship between smoking cessation and standard outcome measures eg second malignancies survival and symptom status in patients treated with these regimens
Compare the effect of these treatment regimens on emotional functioning in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to gender prior neoadjuvant or concurrent adjuvant chemotherapy andor 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
Arm I Patients receive oral bupropion once daily on days 1-3 and twice daily on days 4-77
Arm II Patients receive oral placebo as in arm I Patients are followed at 3 6 and 12 months and then annually for 10 years
PROJECTED ACCRUAL A total of 468 patients 234 117 men and 117 women per arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P02-0215 | OTHER | NCI | None |
| SWOG-S0002 | OTHER | None | None |
| CALGB-79807 | OTHER | None | None |
| ECOG-S0002 | OTHER | None | None |