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S9900: Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

30 de enero de 2013 actualizado por: Southwest Oncology Group

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)

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

354

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Cross Cancer Institute
    • New Brunswick
      • Moncton, New Brunswick, Canadá, E1C 8X3
        • Doctor Leon Richard Oncology Centre
      • Saint John, New Brunswick, Canadá, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canadá, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canadá, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Kingston, Ontario, Canadá, K7L 5P9
        • Kingston Regional Cancer Centre
      • London, Ontario, Canadá, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Ottawa, Ontario, Canadá, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Sudbury, Ontario, Canadá, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital
      • Thunder Bay, Ontario, Canadá, P7B 6V4
        • Northwestern Ontario Regional Cancer Care
      • Toronto, Ontario, Canadá, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canadá, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Fleurimont, Quebec, Canadá, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Montreal, Quebec, Canadá, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canadá, H2L 4MI
        • Centre Hospitalier de l'Universite de Montreal
      • Quebec City, Quebec, Canadá, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canadá, S7N 4H4
        • Saskatoon Cancer Centre
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Huntsville, Alabama, Estados Unidos, 35801
        • Comprehensive Cancer Institute
      • Huntsville, Alabama, Estados Unidos, 35807
        • Huntsville Hospital
      • Mobile, Alabama, Estados Unidos, 36607
        • MBCCOP - Gulf Coast
      • Montgomery, Alabama, Estados Unidos, 36106-3657
        • Montgomery Cancer Center
      • Tuscaloosa, Alabama, Estados Unidos, 35401
        • DCH Cancer Treatment Center
      • Tuscaloosa, Alabama, Estados Unidos, 35401
        • Radiation Oncology Associates of West Alabama
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85013
        • Foundation for Cancer Research and Education
      • Scottsdale, Arizona, Estados Unidos, 85259-5404
        • CCOP - Mayo Clinic Scottsdale Oncology Program
    • California
      • Burbank, California, Estados Unidos, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Concord, California, Estados Unidos, 94524-4110
        • Mount Diablo Medical Center
      • Fresno, California, Estados Unidos, 93720
        • California Cancer Center
      • Fresno, California, Estados Unidos, 93720
        • Saint Agnes Cancer Center
      • Greenbrae, California, Estados Unidos, 94904
        • Sutter Health Western Division Cancer Research Group
      • Loma Linda, California, Estados Unidos, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Estados Unidos, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, Estados Unidos, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, Estados Unidos, 90095-1714
        • Jonsson Comprehensive Cancer Center, UCLA
      • Oakland, California, Estados Unidos, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Pasadena, California, Estados Unidos, 91105
        • Huntington Cancer Center at Huntington Hospital
      • Pomona, California, Estados Unidos, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Sacramento, California, Estados Unidos, 95816
        • Radiation Oncology Centers - Sacramento
      • San Diego, California, Estados Unidos, 92134-3202
        • Naval Medical Center - San Diego
      • San Diego, California, Estados Unidos, 92101
        • Radiation Medical Group, Incorporated
      • San Francisco, California, Estados Unidos, 94115
        • UCSF Comprehensive Cancer Center
      • San Jose, California, Estados Unidos, 95128
        • O'Connor Hospital
      • Santa Rosa, California, Estados Unidos, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Stanford, California, Estados Unidos, 94305-5408
        • Stanford Cancer Center at Stanford University Medical Center
      • Torrance, California, Estados Unidos, 90505
        • Torrance Memorial Medical Center
      • Travis Air Force Base, California, Estados Unidos, 94535
        • David Grant Medical Center
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80909
        • Memorial Hospital Cancer Center
      • Denver, Colorado, Estados Unidos, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver, Colorado, Estados Unidos, 80224
        • CCOP - Colorado Cancer Research Program, Incorporated
      • Grand Junction, Colorado, Estados Unidos, 81502-1628
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
        • Hospital of St. Raphael
      • New Haven, Connecticut, Estados Unidos, 06520-8040
        • Yale Comprehensive Cancer Center
    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20016
        • Sibley Memorial Hospital
    • Florida
      • Daytona Beach, Florida, Estados Unidos, 32114
        • Halifax Medical Center
      • Fort Myers, Florida, Estados Unidos, 33901-8082
        • 21st Century Oncology - Fort Myers
      • Gainesville, Florida, Estados Unidos, 32610-0385
        • Shands Cancer Center at the University of Florida Health Science Center
      • Jacksonville, Florida, Estados Unidos, 32224
        • Mayo Clinic - Jacksonville
      • Jacksonville, Florida, Estados Unidos, 32207
        • Florida Radiation Oncology Group
      • Melbourne, Florida, Estados Unidos, 32901-3276
        • Holmes Regional Medical Center
      • Miami, Florida, Estados Unidos, 33176-2197
        • Baptist Hospital of Miami
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Sylvester Cancer Center
      • Miami Beach, Florida, Estados Unidos, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, Estados Unidos, 32806-2134
        • MD Anderson Cancer Center Orlando
      • Panama City, Florida, Estados Unidos, 32405-4587
        • Gulf Coast Cancer Treatment Center
      • Panama City, Florida, Estados Unidos, 32401
        • Bay Medical Center
      • Sarasota, Florida, Estados Unidos, 34233
        • Sarasota Radiation and Medical Oncology Center
      • Tallahassee, Florida, Estados Unidos, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, Estados Unidos, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, Estados Unidos, 30342-1701
        • CCOP - Atlanta Regional
      • Columbus, Georgia, Estados Unidos, 31901
        • Medical Center/John B. Amos Community Cancer Center
      • Decatur, Georgia, Estados Unidos, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
      • Rome, Georgia, Estados Unidos, 30165
        • Regional Radiation Oncology Center at Rome
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Arlington Heights, Illinois, Estados Unidos, 60005
        • Northwest Community Hospital
      • Chicago, Illinois, Estados Unidos, 60611
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Decatur, Illinois, Estados Unidos, 62526
        • CCOP - Central Illinois
      • Downers Grove, Illinois, Estados Unidos, 60515
        • Cancer Care Center at Advocate Good Samaritan Hospital
      • Harvey, Illinois, Estados Unidos, 60426
        • Ingalls Memorial Hospital
      • Maywood, Illinois, Estados Unidos, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Park Ridge, Illinois, Estados Unidos, 60068
        • Lutheran General Cancer Care Center
      • Peoria, Illinois, Estados Unidos, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Estados Unidos, 61602
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Estados Unidos, 61602
        • CCOP - Scott and White Hospital
      • Urbana, Illinois, Estados Unidos, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Anderson, Indiana, Estados Unidos, 46016
        • St. John's Cancer Center at St. John's Medical Center
      • Bloomington, Indiana, Estados Unidos, 47402
        • Bloomington Hospital
      • Indianapolis, Indiana, Estados Unidos, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
      • Indianapolis, Indiana, Estados Unidos, 46206-1367
        • Methodist Cancer Center at Methodist Hospital
      • Indianapolis, Indiana, Estados Unidos, 46219
        • Community Regional Cancer Care
      • Muncie, Indiana, Estados Unidos, 47303-3499
        • Ball Memorial Hospital Cancer Center
      • South Bend, Indiana, Estados Unidos, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids, Iowa, Estados Unidos, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, Estados Unidos, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Dubuque, Iowa, Estados Unidos, 52001
        • Wendt Regional Cancer Center of Finley Hospital
      • Sioux City, Iowa, Estados Unidos, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67214-3882
        • CCOP - Wichita
    • Kentucky
      • Edgewood, Kentucky, Estados Unidos, 41017
        • St. Elizabeth Medical Center
      • Lexington, Kentucky, Estados Unidos, 40503
        • Central Baptist Hospital
      • Lexington, Kentucky, Estados Unidos, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, Estados Unidos, 40202
        • James Graham Brown Cancer Center at University of Louisville
      • Louisville, Kentucky, Estados Unidos, 40215
        • Louisville Radiation Oncology Center at Caritas Regional Cancer Center
      • Madisonville, Kentucky, Estados Unidos, 42431
        • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70809
        • Mary Bird Perkins Cancer Center
      • New Orleans, Louisiana, Estados Unidos, 70121
        • CCOP - Ochsner
      • New Orleans, Louisiana, Estados Unidos, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, Estados Unidos, 70112-2699
        • Tulane Cancer Center at Tulane University Hospital and Clinic
    • Maine
      • Portland, Maine, Estados Unidos, 04102
        • Maine Medical Center
    • Maryland
      • Annapolis, Maryland, Estados Unidos, 21401
        • Anne Arundel Oncology Center
      • Baltimore, Maryland, Estados Unidos, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, Estados Unidos, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, Estados Unidos, 21204
        • Greater Baltimore Medical Center and Cancer Center
      • Baltimore, Maryland, Estados Unidos, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Baltimore, Maryland, Estados Unidos, 21215-1290
        • Harbor Hospital Center
      • Baltimore, Maryland, Estados Unidos, 21229
        • St. Agnes Cancer Center
      • Salisbury, Maryland, Estados Unidos, 21801
        • Peninsula Regional Medical Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Estados Unidos, 02118
        • Cancer Research Center at Boston Medical Center
      • Boston, Massachusetts, Estados Unidos, 02111
        • TUFTS - New England Medical Center
      • Boston, Massachusetts, Estados Unidos, 02114
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Hyannis, Massachusetts, Estados Unidos, 02601
        • Cape Cod Hospital
      • Jamaica Plain, Massachusetts, Estados Unidos, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
      • Peabody, Massachusetts, Estados Unidos, 01960
        • NSMC Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, Estados Unidos, 48109-0010
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Estados Unidos, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Estados Unidos, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Flint, Michigan, Estados Unidos, 48503
        • Hurley Medical Center
      • Flint, Michigan, Estados Unidos, 48532-3685
        • McLaren Regional Cancer Center
      • Kalamazoo, Michigan, Estados Unidos, 49007-3731
        • CCOP - Kalamazoo
      • Marquette, Michigan, Estados Unidos, 49855
        • Marquette General Hospital
      • Midland, Michigan, Estados Unidos, 48670
        • MidMichigan Medical Center - Midland
      • Royal Oak, Michigan, Estados Unidos, 48073
        • William Beaumont Hospital - Royal Oak
      • Royal Oak, Michigan, Estados Unidos, 48073-6769
        • CCOP - Beaumont
      • Troy, Michigan, Estados Unidos, 48085
        • William Beaumont Hospital - Troy
    • Minnesota
      • Duluth, Minnesota, Estados Unidos, 55805
        • CCOP - Duluth
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Fairview University Medical Center - University Campus
      • Minneapolis, Minnesota, Estados Unidos, 55417-2399
        • Veterans Affairs Medical Center - Minneapolis
      • Rochester, Minnesota, Estados Unidos, 55905-0001
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Estados Unidos, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Estados Unidos, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Estados Unidos, 63110-0250
        • St. Louis University Hospital Cancer Center
      • Springfield, Missouri, Estados Unidos, 65807
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Estados Unidos, 65807
        • Cancer Research for the Ozarks
      • St. Louis, Missouri, Estados Unidos, 63110
        • Siteman Cancer Center
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • CCOP - Montana Cancer Consortium
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Estados Unidos, 68114-4199
        • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
      • Omaha, Nebraska, Estados Unidos, 68198-7521
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas, Nevada, Estados Unidos, 89109
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, Estados Unidos, 03103
        • Elliot Regional Cancer Center
    • New Jersey
      • East Orange, New Jersey, Estados Unidos, 07019
        • Veterans Affairs Medical Center - East Orange
      • Edison, New Jersey, Estados Unidos, 08818
        • John F. Kennedy Medical Center
      • Elizabeth, New Jersey, Estados Unidos, 07201
        • Trinitas Hospital - Jersey Street Campus
      • Long Branch, New Jersey, Estados Unidos, 07740-6395
        • Monmouth Medical Center
      • Millville, New Jersey, Estados Unidos, 08332
        • South Jersey Regional Cancer Center
      • Mount Holly, New Jersey, Estados Unidos, 08060
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
      • New Brunswick, New Jersey, Estados Unidos, 08903
        • Cancer Institute of New Jersey
      • Newark, New Jersey, Estados Unidos, 07112
        • Newark Beth Israel Medical Center
      • Pomona, New Jersey, Estados Unidos, 08240
        • Atlantic City Medical Center
      • Princeton, New Jersey, Estados Unidos, 08540
        • Medical Center of Princeton
      • Ridgewood, New Jersey, Estados Unidos, 07450
        • Valley Hospital
      • Toms River, New Jersey, Estados Unidos, 08755
        • Community Medical Center
      • Trenton, New Jersey, Estados Unidos, 08629
        • Fox Chase Cancer Center at St. Francis Medical Center
      • Warren, New Jersey, Estados Unidos, 07059
        • Associated Radiologists, P.A.
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87109
        • Radiation Oncology Associates of Albuquerque
    • New York
      • Albany, New York, Estados Unidos, 12208
        • Cancer Center of Albany Medical Center
      • Bronx, New York, Estados Unidos, 10466
        • MBCCOP-Our Lady of Mercy Cancer Center
      • Brooklyn, New York, Estados Unidos, 11203
        • SUNY downstate Medical Center
      • Brooklyn, New York, Estados Unidos, 11215
        • New York Methodist Hospital
      • Buffalo, New York, Estados Unidos, 14263-0001
        • Roswell Park Cancer Institute
      • Clifton Springs, New York, Estados Unidos, 14432
        • Finger Lakes Radiation Oncology Center
      • East Syracuse, New York, Estados Unidos, 13057
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Manhasset, New York, Estados Unidos, 11030
        • CCOP - North Shore University Hospital
      • New York, New York, Estados Unidos, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Estados Unidos, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • New York, New York, Estados Unidos, 10003
        • Beth Israel Medical Center - Philipps Ambulatory Care Center
      • Plattsburgh, New York, Estados Unidos, 12901-1490
        • Champlain Valley Physicians Hospital Medical Center
      • Poughkeepsie, New York, Estados Unidos, 12601
        • Vassar Brothers Medical Center
      • Rochester, New York, Estados Unidos, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Yonkers, New York, Estados Unidos, 10701
        • Riverhill Radiation Oncology
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Concord, North Carolina, Estados Unidos, 28025
        • Batte Cancer Center at Northeast Medical Center
      • Greenville, North Carolina, Estados Unidos, 27835-6028
        • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, Estados Unidos, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501-5505
        • Medcenter One Health System
      • Fargo, North Dakota, Estados Unidos, 58122
        • CCOP - Merit Care Hospital
      • Grand Forks, North Dakota, Estados Unidos, 58201
        • Altru Cancer Center
      • Minot, North Dakota, Estados Unidos, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, Estados Unidos, 44302
        • Akron General Medical Center
      • Akron, Ohio, Estados Unidos, 44304
        • Akron City Hospital
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Cancer Center at Christ Hospital
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Estados Unidos, 44106
        • University Hospitals of Cleveland
      • Cleveland, Ohio, Estados Unidos, 44106-5065
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Columbus, Ohio, Estados Unidos, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
      • Columbus, Ohio, Estados Unidos, 43206
        • CCOP - Columbus
      • Dayton, Ohio, Estados Unidos, 45429
        • CCOP - Dayton
      • Parma, Ohio, Estados Unidos, 44129
        • Parma Community General Hospital
      • Toledo, Ohio, Estados Unidos, 43623-3456
        • CCOP - Toledo Community Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Oklahoma University Medical Center
      • Oklahoma City, Oklahoma, Estados Unidos, 73102
        • Frank C. Love Cancer Institute at St. Anthony Hospital
      • Tulsa, Oklahoma, Estados Unidos, 74136
        • CCOP - Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74104
        • St. John Health System
    • Oregon
      • Portland, Oregon, Estados Unidos, 97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Abington, Pennsylvania, Estados Unidos, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, Estados Unidos, 18105
        • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
      • Bethlehem, Pennsylvania, Estados Unidos, 18015
        • St. Luke's Hospital Cancer Center
      • Danville, Pennsylvania, Estados Unidos, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Danville, Pennsylvania, Estados Unidos, 17822-2001
        • Geisinger Medical Center
      • Darby, Pennsylvania, Estados Unidos, 19023
        • Mercy Fitzgerald Hospital
      • Drexel Hill, Pennsylvania, Estados Unidos, 19026
        • Delaware County Memorial Hospital
      • East Stroudsburg, Pennsylvania, Estados Unidos, 18301
        • Dale and Frances Hughes Cancer Center
      • Hershey, Pennsylvania, Estados Unidos, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Veterans Affairs Medical Center - Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19141-3098
        • Albert Einstein Cancer Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Abramson Cancer Center at University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, Estados Unidos, 15219
        • Mercy Hospital of Pittsburgh
      • Pittsburgh, Pennsylvania, Estados Unidos, 15236
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Reading, Pennsylvania, Estados Unidos, 19612-6052
        • Reading Hospital and Medical Center
      • Scranton, Pennsylvania, Estados Unidos, 18501
        • Mercy Hospital Cancer Center - Scranton
      • Wilkes-Barre, Pennsylvania, Estados Unidos, 18764-0001
        • Wilkes-Barre General Hospital
      • Wynnewood, Pennsylvania, Estados Unidos, 19096
        • CCOP - MainLine Health
      • York, Pennsylvania, Estados Unidos, 17403
        • Wellspan Health - York Cancer Center
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02908-4735
        • Roger Williams Medical Center
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • CCOP - Upstate Carolina
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57709
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Estados Unidos, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Tennessee
      • Jackson, Tennessee, Estados Unidos, 38301
        • West Tennessee Cancer Center at Jackson-Madison County General Hospital
      • Nashville, Tennessee, Estados Unidos, 37232-5671
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Amarillo, Texas, Estados Unidos, 79106
        • Harrington Cancer Center
      • Arlington, Texas, Estados Unidos, 76012
        • Arlington Cancer Center
      • Galveston, Texas, Estados Unidos, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, Estados Unidos, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Lackland Air Force Base, Texas, Estados Unidos, 78236-5300
        • Wilford Hall Medical Center
      • Lubbock, Texas, Estados Unidos, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center
      • Pasadena, Texas, Estados Unidos, 77504
        • Bayshore Medical Center
      • San Antonio, Texas, Estados Unidos, 78284-7811
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • Cottonwood Hospital Medical Center
      • Provo, Utah, Estados Unidos, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Estados Unidos, 84770
        • Dixie Regional Medical Center
      • Salt Lake City, Utah, Estados Unidos, 84132
        • University of Utah Health Sciences Center
      • Salt Lake City, Utah, Estados Unidos, 84143
        • LDS Hospital
    • Vermont
      • Bennington, Vermont, Estados Unidos, 05201
        • Green Mountain Oncology Group
      • Burlington, Vermont, Estados Unidos, 05405-0075
        • Vermont Cancer Center at University of Vermont
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • Cancer Center at the University of Virginia
      • Harrisonburg, Virginia, Estados Unidos, 22801
        • RMH Regional Cancer Center
      • Portsmouth, Virginia, Estados Unidos, 23708-2197
        • Naval Medical Center, Portsmouth
      • Richmond, Virginia, Estados Unidos, 23226
        • Bon Secours - St. Mary's Hospital
      • Richmond, Virginia, Estados Unidos, 23298-0124
        • Massey Cancer Center at Virginia Commonwealth University
    • Washington
      • Seattle, Washington, Estados Unidos, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Seattle, Washington, Estados Unidos, 98111
        • Cancer Institute at Virginia Mason Medical Center
      • Spokane, Washington, Estados Unidos, 99204
        • Deaconess Medical Center
      • Yakima, Washington, Estados Unidos, 98902
        • Yakima Valley Memorial Hospital
    • West Virginia
      • Wheeling, West Virginia, Estados Unidos, 26003
        • Schiffler Cancer Center at Wheeling Hospital
    • Wisconsin
      • Green Bay, Wisconsin, Estados Unidos, 54307-3508
        • St. Vincent Hospital
      • Green Bay, Wisconsin, Estados Unidos, 54307-3453
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • La Crosse, Wisconsin, Estados Unidos, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Estados Unidos, 53705
        • Veterans Affairs Medical Center - Madison
      • Madison, Wisconsin, Estados Unidos, 53713
        • Southern Wisconsin Radiotherapy Center
      • Madison, Wisconsin, Estados Unidos, 53792-0001
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Menomonee Falls, Wisconsin, Estados Unidos, 53051
        • Community Memorial Hospital
      • Milwaukee, Wisconsin, Estados Unidos, 53211
        • Columbia Hospital
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • St. Luke's Medical Center
      • Milwaukee, Wisconsin, Estados Unidos, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin Cancer Center
      • Racine, Wisconsin, Estados Unidos, 53405
        • All Saints Cancer Center at All Saints Healthcare
      • Waukesha, Wisconsin, Estados Unidos, 53188
        • Waukesha Memorial Hospital Regional Cancer Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: preooperative chemo followed by surgery
carboplatin paclitaxel conventional surgery
Droga: carboplatino
Procedimiento: cirugía convencional
Droga: paclitaxel
Comparador activo: Surgery alone
conventional surgery
Procedimiento: cirugía convencional

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Southwest Oncology Group

Colaboradores

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
North Central Cancer Treatment Group

Investigadores

  • Silla de estudio: Corey J. Langer, MD, Fox Chase Cancer Center
  • Silla de estudio: Joseph A. Treat, MD, Fox Chase Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 1999

Finalización primaria (Actual)

1 de mayo de 2005

Finalización del estudio (Actual)

1 de noviembre de 2012

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 1999

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2003

Publicado por primera vez (Estimar)

27 de enero de 2003

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

31 de enero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

30 de enero de 2013

Última verificación

1 de enero de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000067223
  • U10CA032102 (Subvención/contrato del NIH de EE. UU.)
  • S9900 (Otro identificador: NCCTG)
  • RTOG-L0015 (Otro identificador: RTOG)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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