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Surgery With or Without Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004011
  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 if surgery plus combination chemotherapy is more effective than surgery alone 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 non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Procedure: conventional surgery
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB (T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


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

Study Start Date: October 1999
Detailed Description:

OBJECTIVES:

  • Compare survival of patients with previously untreated stage IB, II, or selected IIIA non-small cell lung cancer after preoperative chemotherapy comprising paclitaxel and carboplatin plus surgery vs surgery alone.
  • Compare these regimens in terms of operative mortality and other toxic effects in these patients.
  • Evaluate the response rates (confirmed and unconfirmed) and toxic effects associated with combined paclitaxel and carboplatin in these patients.
  • Obtain samples for correlation of radiologic, pathologic, molecular, and biologic factors with the outcome in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical stage (IB or IIA vs IIB or IIIA).

Patients are randomized to one of two treatment arms:

  • Arm I: Patients undergo thoracotomy. All accessible hilar (level 10) lymph nodes are dissected, and complete mediastinal lymph node sampling is performed.
  • Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of course 3, patients undergo thoracotomy and lymph node dissection as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually until year 10.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 4 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:

    • Stage IB (T2, N0)
    • Stage II

      • T1-2, N1 with negative mediastinoscopy OR
      • T3, N0
    • Selected stage IIIA with negative mediastinoscopies

      • T3, N1, excluding superior sulcus
      • Positive level 10 hilar nodes allowed if mediastinoscopy negative
  • Apical tumors with no clinical symptoms allowed
  • No symptomatic tumors (T3, N0 or T3, N1) involving the superior sulcus

    • No Pancoast's tumors
  • Negative mediastinoscopy required in all patients with clinically positive mediastinal or hilar lymph nodes to ensure no N2 disease
  • Bidimensionally measurable or evaluable disease by chest x-ray or contrast-enhanced CT scan

    • T3, N0 disease assessable only by bronchoscopy must be affirmed by 2 observers and documented by photograph that includes main carina

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0 or 1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • WBC at least 4,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min

Pulmonary:

  • See Disease Characteristics
  • Preresection FEV_1 greater than 2.0 L OR
  • Predicted postresection FEV_1 greater than 1.0 L
  • No postobstructive pneumonia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious infection
  • No other serious medical condition that would preclude study compliance
  • No prior allergic reactions to drugs containing Cremophor
  • No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy for NSCLC
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior systemic radiotherapy for NSCLC
  • No concurrent radiotherapy

Surgery:

  • At least 5 years since prior resection of lung disease

Other:

  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004011

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
Huntsville Hospital
Huntsville, Alabama, United States, 35807
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
Montgomery Cancer Center
Montgomery, Alabama, United States, 36106-3657
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, United States, 35401
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
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
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1714
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States, 91105
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
O'Connor Hospital
San Jose, California, United States, 95128
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Radiation Medical Group, Incorporated
San Diego, California, United States, 92101
Radiation Oncology Centers - Sacramento
Sacramento, California, United States, 95816
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5408
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Torrance Memorial Medical Center
Torrance, California, United States, 90505
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
St. Mary's Regional Cancer Center at St. 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
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
21st Century Oncology - Fort Myers
Fort Myers, Florida, United States, 33901-8082
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Bay Medical Center
Panama City, Florida, United States, 32401
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Radiation Oncology Group
Jacksonville, Florida, United States, 32207
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901-3276
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806-2134
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31901
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Scott and White Hospital
Peoria, Illinois, United States, 61602
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Ball Memorial Hospital Cancer Center
Muncie, Indiana, United States, 47303-3499
Bloomington Hospital
Bloomington, Indiana, United States, 47402
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Community Regional Cancer Care
Indianapolis, Indiana, United States, 46219
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, United States, 46016
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Madisonville, Kentucky, United States, 42431
Louisville Radiation Oncology Center at Caritas Regional Cancer Center
Louisville, Kentucky, United States, 40215
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 Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112-2699
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
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
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
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, 02114
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
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
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
Marquette General Hospital
Marquette, Michigan, United States, 49855
Hurley Medical Center
Flint, Michigan, United States, 48503
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
McLaren Regional Cancer Center
Flint, Michigan, United States, 48532-3685
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0010
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417-2399
United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
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
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
St. Louis University Hospital Cancer 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 at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7521
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
United States, New Hampshire
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical 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
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Medical Center of Princeton
Princeton, New Jersey, United States, 08540
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
Valley Hospital
Ridgewood, New Jersey, United States, 07450
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 - Philipps Ambulatory Care Center
New York, New York, United States, 10003
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901-1490
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
SUNY Downstate Medical Center
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
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
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
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville, North Carolina, United States, 27835-6028
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, North Dakota
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44302
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Cancer Center at Christ Hospital
Cincinnati, Ohio, United States, 45219
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
CCOP - Columbus
Columbus, Ohio, United States, 43206
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
MetroHealth's Cancer Care Center at MetroHealth Medical 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
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73102
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
St. John Health System
Tulsa, Oklahoma, United States, 74104
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Dale and Frances Hughes Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
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
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
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, 18764-0001
United States, Rhode Island
Roger Williams Medical Center
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
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-5671
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Bayshore Medical Center
Pasadena, Texas, United States, 77504
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Harrington Cancer Center
Amarillo, Texas, United States, 79106
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
LDS 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
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0124
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
United States, Washington
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Deaconess Medical Center
Spokane, Washington, United States, 99204
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98111
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54307-3453
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
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, 53792-0001
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
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-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Northwestern Ontario Regional Cancer Care
Thunder Bay, Ontario, Canada, P7B 6V4
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital
Sudbury, Ontario, Canada, P3E 5J1
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
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
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Investigators
Study Chair: Paul A. Bunn, MD University of Colorado at Denver and Health Sciences Center
Study Chair: Joseph A. Treat, MD Fox Chase Cancer Center CCOP Research Base
Study Chair: Randolph S. Marks, MD Mayo Clinic
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Pisters K, Vallieres E, Bunn PA, et al.: S9900: surgery alone or surgery plus induction (ind) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): follow-up on a phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7520, 389s, 2007.
Pisters K, Vallieres E, Bunn P, et al.: S9900: a phase III trial of surgery alone or surgery plus preoperative (preop) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7012, 624s, 2005.

Study ID Numbers: CDR0000067223, SWOG-S9900, ECOG-S9900, NCCTG-S9900, RTOG-L0015
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004011     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
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 30, 2009