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

30 gennaio 2013 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

354

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: preooperative chemo followed by surgery
carboplatin paclitaxel conventional surgery
Comparatore attivo: Surgery alone
conventional surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Corey J. Langer, MD, Fox Chase Cancer Center
  • Cattedra di studio: Joseph A. Treat, MD, Fox Chase Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 1999

Completamento primario (Effettivo)

1 maggio 2005

Completamento dello studio (Effettivo)

1 novembre 2012

Date di iscrizione allo studio

Primo inviato

1 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

31 gennaio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 gennaio 2013

Ultimo verificato

1 gennaio 2013

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro ai polmoni

Prove cliniche su carboplatino

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