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

30. januar 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

354

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: preooperative chemo followed by surgery
carboplatin paclitaxel conventional surgery
Legemiddel: karboplatin
Fremgangsmåte: konvensjonell kirurgi
Legemiddel: paklitaksel
Aktiv komparator: Surgery alone
conventional surgery
Fremgangsmåte: konvensjonell kirurgi

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Southwest Oncology Group

Samarbeidspartnere

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

Etterforskere

  • Studiestol: Corey J. Langer, MD, Fox Chase Cancer Center
  • Studiestol: Joseph A. Treat, MD, Fox Chase Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 1999

Primær fullføring (Faktiske)

1. mai 2005

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000067223
  • U10CA032102 (U.S. NIH-stipend/kontrakt)
  • S9900 (Annen identifikator: NCCTG)
  • RTOG-L0015 (Annen identifikator: RTOG)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere