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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 Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often get the best healthcare available for their 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 condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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 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
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
For Condition: stage 1 non-small cell lung cancer,stage 2 non-small cell lung cancer,Non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI),Cancer and Leukemia Group B,Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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 (e.g., 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 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. - 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.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage I or II non-small cell lung cancer with complete resection of all disease - Must be free of recurrent or progressive disease - Current smoker defined as: - Smoked at least 100 cigarettes in entire life AND - Currently smoking some days or every day - 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: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - Not within an immediate post-infarction period - No uncontrolled arrhythmias - No unstable angina - No uncontrolled hypertension (unstable blood pressure, diastolic pressure 90 mm Hg or greater) Other: - Must be able to read, speak, and understand English - Must be willing to allow testing of saliva for cotinine levels - No history of seizures - No history of eating disorders - No known drug-drug interactions between nicotine patch and/or bupropion and patient's current or planned medications including chemotherapy and antiemetics - No concurrent psychiatric diagnosis that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Concurrent adjuvant chemotherapy allowed Endocrine therapy: - No concurrent systemic steroids Radiotherapy: - Concurrent adjuvant radiotherapy allowed Surgery: - See Disease Characteristics - Recovered from prior surgery Other: - Prior neoadjuvant therapy allowed - At least 14 days since prior medications containing bupropion (e.g., Wellbutrin or Wellbutrin SR) - No other concurrent medications that contain bupropion (e.g., Wellbutrin or Wellbutrin SR) - No concurrent monoamine oxidase inhibitors - No concurrent medications that lower seizure threshold (e.g., antipsychotics, antidepressants, or theophylline) - No other concurrent nicotine replacement therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EllenGritz, Study Chair, M.D. Anderson Cancer Center
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Lombardi Cancer Center of Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05401-3498
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97201-3098
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0501
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Additional Information:
Study ID Numbers: CDR0000069256; NCI-P02-0215,ECOG-S0002,CALGB-79807,SWOG-S0002
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032084
Other Non-Small Cell Lung Cancer Studies:
1. Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
2. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
3. Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
4. Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
5. Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
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Other Non-small cell lung cancer Clinical Trials
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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
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