Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

30. januar 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Lungekræft

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

354

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: preooperative chemo followed by surgery carboplatin paclitaxel conventional surgery	Medicin: carboplatin Procedure: konventionel kirurgi Medicin: paclitaxel
Aktiv komparator: Surgery alone conventional surgery	Procedure: konventionel kirurgi

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Radiation Therapy Oncology Group

North Central Cancer Treatment Group

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Pisters KM, Vallieres E, Crowley JJ, Franklin WA, Bunn PA Jr, Ginsberg RJ, Putnam JB Jr, Chansky K, Gandara D. Surgery with or without preoperative paclitaxel and carboplatin in early-stage non-small-cell lung cancer: Southwest Oncology Group Trial S9900, an intergroup, randomized, phase III trial. J Clin Oncol. 2010 Apr 10;28(11):1843-9. doi: 10.1200/JCO.2009.26.1685. Epub 2010 Mar 15.
Pisters K, Vallieres E, Bunn PA, et al.: S9900: surgery alone or surgery plus induction (ind) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): follow-up on a phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7520, 389s, 2007.
Pisters K, Vallieres E, Bunn P, et al.: S9900: a phase III trial of surgery alone or surgery plus preoperative (preop) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7012, 624s, 2005.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 1999

Primær færdiggørelse (Faktiske)

1. maj 2005

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000067223
U10CA032102 (U.S. NIH-bevilling/kontrakt)
S9900 (Anden identifikator: NCCTG)
RTOG-L0015 (Anden identifikator: RTOG)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Mansoura University

Rekruttering

Sammenligning af tre metoder til PEEP-titrering under én lungeventilation i liggende stilling

One Lung Ventilation

Egypten
Chinese Chronic Respiratory Disease Research Network

Rekruttering

Kohorteundersøgelse af lungeknudeintervention (LNICS)

Hændelse Lung Nodule

Kina
Dokuz Eylul University

Afsluttet

Evaluering af en lungeventilation med ultralyd ved thoraxkirurgiske operationer

One Lung Ventilation

Kalkun
Seoul National University Hospital

Afsluttet

Effektiviteten af Lung Sono i One-lung Ventilation

One Lung Ventilation

Korea, Republikken
Seoul National University Hospital

Afsluttet

Forkonditionering af One-lung Ventilation

One Lung Ventilation

Korea, Republikken
Yonsei University

Afsluttet

Positivt endeekspiratorisk tryk og alveolær rekruttering til én lungeventilation

One Lung Ventilation

Korea, Republikken
Sichuan University
West China Hospital

Midlertidigt ikke tilgængelig

Ændringen af pulmonal blodgennemstrømning under én lungeventilation

One Lung Ventilation
Joseph D. Tobias

Afsluttet

Intracuff-tryk under en-lungeventilation hos spædbørn og børn

One-lung Ventilation (OLV)

Forenede Stater
University Health Network, Toronto

Aktiv, ikke rekrutterende

TorEx lungeperfusionssystem

Lungetransplantation | Ex Vivo Lung Perfusion

Canada
Papa Giovanni XXIII Hospital

Afsluttet

Ex Vivo Lungeperfusion i Bergamo Lungetransplantationsprogram

Lungetransplantation | Ex Vivo Lung Perfusion

Italien

Kliniske forsøg med carboplatin

Eisai Inc.

Afsluttet

En dosisfindende undersøgelse af E7389 i kombination med carboplatin hos patienter med solide tumorer

Kræft

Forenede Stater, Østrig, Indien
Samyang Biopharmaceuticals Corporation

Afsluttet

Bestem MTD, evaluer effektiviteten og sikkerheden af Genexol®-PM Plus Carboplatin med avanceret ovariecancer

Livmoderhalskræft
NHS Greater Glasgow and Clyde

Afsluttet

Carboplatin til behandling af patienter med stadium IC-IV ovarie-, æggeleder- eller primær peritoneal cancer

Livmoderhalskræft | Æggelederkræft | Primær peritoneal kræft

Det Forenede Kongerige, Australien, New Zealand
Duke University

Afsluttet

Carboplatin hos patienter med progressive gliomer

Tumorer i hjernen og centralnervesystemet

Forenede Stater, Canada
National Cancer Institute (NCI)
Children's Oncology Group

Afsluttet

Lobradimil og Carboplatin til behandling af børn med hjernetumorer

Tumorer i hjernen og centralnervesystemet

Forenede Stater, Canada, Puerto Rico, Australien, Holland, New Zealand, Schweiz
All India Institute of Medical Sciences, New Delhi
Council of Scientific and Industrial Research, India

Ukendt

Forsøg, der sammenligner to carboplatindoser i gruppe C og D intraokulært retinoblastom

Intraokulært retinoblastom

Indien
National Cancer Institute (NCI)

Afsluttet

AZD2281 Plus Carboplatin til behandling af bryst- og æggestokkræft

Brystkræft | Livmoderhalskræft

Forenede Stater
Medical Research Council
European Organisation for Research and Treatment of Cancer - EORTC

Afsluttet

Stråleterapi sammenlignet med kemoterapi ved behandling af patienter med trin I testikelkræft

Testikulær kimcelletumor

Det Forenede Kongerige, Canada, Norge, Holland, Sydafrika, Brasilien, Finland
Akeso

Rekruttering

AK112 i kombination med kemoterapi ved avanceret planocellulær ikke-småcellet lungekræft

Avanceret pladeepitel, ikke-småcellet lungekræft

Kina
Rennes University Hospital

Afsluttet

Undersøgelse af prædiktive faktorer for kemoresistens i ovariecancer (FaCliBioCCo)

Livmoderhalskræft

Frankrig

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

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)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Lungekræft

Kliniske forsøg med carboplatin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guatemala

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer