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

30 januari 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

354

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: preooperative chemo followed by surgery
carboplatin paclitaxel conventional surgery
Geneesmiddel: carboplatine
Procedure: conventionele chirurgie
Geneesmiddel: paclitaxel
Actieve vergelijker: Surgery alone
conventional surgery
Procedure: conventionele chirurgie

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Southwest Oncology Group

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 1999

Primaire voltooiing (Werkelijk)

1 mei 2005

Studie voltooiing (Werkelijk)

1 november 2012

Studieregistratiedata

Eerst ingediend

1 november 1999

Eerst ingediend dat voldeed aan de QC-criteria

26 januari 2003

Eerst geplaatst (Schatting)

27 januari 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

31 januari 2013

Laatste update ingediend die voldeed aan QC-criteria

30 januari 2013

Laatst geverifieerd

1 januari 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CDR0000067223
  • U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
  • S9900 (Andere identificatie: NCCTG)
  • RTOG-L0015 (Andere identificatie: RTOG)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren