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Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: June 6, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborators: National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002852
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Procedure: adjuvant therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 500
Study Start Date: October 1996
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the prevalence of 10 molecular biological markers (growth factors HER-2/neu and K-ras codon 12 mutations, cell cycle factors Ki-67 and rb, apoptosis factors p53 and bcl-2, angiogenesis factor viii, and adhesion protein CD-44 plus motility factor gelsolin) in patients with resected stage IB non-small cell lung cancer considered to be at high risk of recurrence.
  • Compare the prognostic importance of specific markers on the failure-free survival of patients treated with paclitaxel and carboplatin vs no adjuvant therapy after resection.
  • Determine the influence of adjuvant chemotherapy on cancer-free survival relative to marker expression in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.

  • Arm I:Patients receive no further therapy.
  • Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.

Patients are followed every 4 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 2.8 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven completely resected stage IB non-small cell lung cancer

    • Surgically staged T2 N0 M0 disease
    • Prior lobectomy or pneumonectomy with resection of associated N1 lymph nodes by thoracotomy or thoracoscopy required

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,800/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT less than 2 times upper limit of normal

Renal:

  • Not specified

Other:

  • No other prior malignancy except curatively treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or surgically treated carcinoma in situ of the breast
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent colony-stimulating factor therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002852

  Hide Study Locations
Locations
United States, Alabama
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-3657
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
California Cancer Center
Fresno, California, United States, 93720
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
O'Connor Hospital
San Jose, California, United States, 95128
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Huntington Cancer Center
Pasadena, California, United States, 91105
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1714
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Radiation Medical Group, Incorporated
San Diego, California, United States, 92101
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, United States, 91767
Saint Agnes Cancer Center
Fresno, California, United States, 93720
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Torrance Memorial Medical Center
Torrance, California, United States, 90505
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
St. Joseph's Regional Health System
Stockton, California, United States, 95204
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502-1628
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Connecticut
Hospital of St. Raphael
New Haven, Connecticut, United States, 06511
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8040
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Center for Sickle Cell Disease
Washington, District of Columbia, United States, 20059
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
United States, Florida
21st Century Oncology - Fort Myers
Fort Myers, Florida, United States, 33901-8082
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
Bay Medical Center
Panama City, Florida, United States, 32401
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Florida Radiation Oncology Group
Jacksonville, Florida, United States, 32207
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States, 33401
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901-3276
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806-2134
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States, 33021
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31901
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Scott and White Hospital
Peoria, Illinois, United States, 61602
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Bloomington Hospital
Bloomington, Indiana, United States, 47402
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Clarian Health Partners Inc.
Indianapolis, Indiana, United States, 46206-1367
Community Regional Cancer Care
Indianapolis, Indiana, United States, 46219
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
Oncology Institute of Greater Lafayette
Lafayette, Indiana, United States, 47904
St. John's Medical Center
Anderson, Indiana, United States, 46016
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0293
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
Cancer Center at Lexington Clinic
Lexington, Kentucky, United States, 40504
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Louisville Radiation Oncology
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Anne Arundel Oncology Center
Annapolis, Maryland, United States, 21401
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
St. Agnes Cancer Center
Baltimore, Maryland, United States, 21229
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
NSMC Cancer Center
Peabody, Massachusetts, United States, 01960
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Marquette General Hospital
Marquette, Michigan, United States, 49855
McLaren Regional Cancer Center
Flint, Michigan, United States, 48532-3685
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0010
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview University Medical Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63108
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
Nebraska Health System
Omaha, Nebraska, United States, 68198-7460
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Associated Radiologists, P.A.
Warren, New Jersey, United States, 07059
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
Community Medical Center
Toms River, New Jersey, United States, 08755
Cooper University Hospital
Camden, New Jersey, United States, 08103
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Medical Center of Princeton
Princeton, New Jersey, United States, 08540
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Somerset Medical Center
Somerville, New Jersey, United States, 08876
Valley Hospital
Ridgewood, New Jersey, United States, 07450
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
United States, New Mexico
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Lourdes Regional Cancer Center
Binghamton, New York, United States, 13905
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Methodist Hospital
Brooklyn, New York, United States, 11215
North Shore Radiation Oncology
Setauket, New York, United States, 11733
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
United States, North Carolina
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
Cape Fear Valley Health System
Fayetteville, North Carolina, United States, 28302-2000
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States, 28503-1678
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
NorthEast Oncology Associates
Concord, North Carolina, United States, 28025
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States, 58102
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
CCOP - Dayton
Dayton, Ohio, United States, 45429
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Cancer Center at Christ Hospital
Cincinnati, Ohio, United States, 45219
CCOP - Columbus
Columbus, Ohio, United States, 43206
Akron General Medical Center
Akron, Ohio, United States, 44302
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Parma Community General Hospital
Parma, Ohio, United States, 44129
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73101
St. John Health System
Tulsa, Oklahoma, United States, 74104
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Wellspan Health - York Cancer Center
York, Pennsylvania, United States, 17403
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
United States, Rhode Island
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301-3956
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0075
United States, Virginia
Bon Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23226
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22902
Massey Cancer Center
Richmond, Virginia, United States, 23298-0058
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
United States, Washington
Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Deaconess Medical Center
Spokane, Washington, United States, 99204
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
All Saints Cancer Center
Racine, Wisconsin, United States, 53405
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States, 54501
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4MI
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Cancer and Leukemia Group B
Radiation Therapy Oncology Group
Investigators
Study Chair: Gary M. Strauss, MD Rhode Island Hospital Comprehensive Cancer Center
Study Chair: David W. Johnstone, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
Publications:
Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant Paclitaxel Plus Carboplatin Compared With Observation in Stage IB Non-Small-Cell Lung Cancer: CALGB 9633 With the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Sep 22; [Epub ahead of print]
Strauss GM, Herndon JE, Maddaus MA, et al.: Adjuvant chemotherapy in stage IB non-small cell lung cancer (NSCLC): update of Cancer and Leukemia Group B (CALGB) protocol 9633. [Abstract] J Clin Oncol 24 (Suppl 18): A-7007, 2006.
Strauss GM, Herndon J, Maddaus MA, et al.: Randomized clinical trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in stage IB non-small cell lung cancer (NSCLC): report of Cancer and Leukemia Group B (CALGB) protocol 9633. [Abstract] J Clin Oncol 22 (Suppl 14): A-7019, 621s, 2004.
Close JL, Daniels L, Allegra CJ, et al.: Impact of 2006 ASCO Annual Meeting data release of Cancer and Leukemia Group B (CALGB) protocol 9633 on practice patterns in the United States. [Abstract] J Clin Oncol 26 (Suppl 15): A-7547, 2008.
Kassam F, Shepherd FA, Johnston M, Visbal A, Feld R, Darling G, Keshavjee S, Pierre A, Waddell T, Leighl NB. Referral patterns for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. J Thorac Oncol. 2007 Jan;2(1):39-43.
Hotta K, Matsuo K, Kiura K, Ueoka H, Tanimoto M. Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol. 2006 Mar;18(2):144-50. Review.
Wakelee HA, Schiller JH, Gandara DR. Current status of adjuvant chemotherapy for stage IB non-small-cell lung cancer: implications for the New Intergroup Trial. Clin Lung Cancer. 2006 Jul;8(1):18-21. Review.
Visbal AL, Leighl NB, Feld R, Shepherd FA. Adjuvant Chemotherapy for Early-Stage Non-small Cell Lung Cancer. Chest. 2005 Oct;128(4):2933-43. Review.

Study ID Numbers: CDR0000065095, CALGB-9633, RTOG-9616, CLB-C9633
Study First Received: November 1, 1999
Last Updated: June 6, 2009
ClinicalTrials.gov Identifier: NCT00002852     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Adjuvants, Immunologic
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009