S9900: Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
30 januari 2013 uppdaterad av: Southwest Oncology Group
A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB (T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if surgery plus combination chemotherapy is more effective than surgery alone for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have non-small cell lung cancer.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
354
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Förenta staterna, 35801
- Comprehensive Cancer Institute
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Huntsville, Alabama, Förenta staterna, 35807
- Huntsville Hospital
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Mobile, Alabama, Förenta staterna, 36607
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Förenta staterna, 36106-3657
- Montgomery Cancer Center
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Tuscaloosa, Alabama, Förenta staterna, 35401
- DCH Cancer Treatment Center
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Tuscaloosa, Alabama, Förenta staterna, 35401
- Radiation Oncology Associates of West Alabama
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Arizona
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Phoenix, Arizona, Förenta staterna, 85013
- Foundation for Cancer Research and Education
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Scottsdale, Arizona, Förenta staterna, 85259-5404
- CCOP - Mayo Clinic Scottsdale Oncology Program
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California
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Burbank, California, Förenta staterna, 91505
- Providence Saint Joseph Medical Center - Burbank
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Concord, California, Förenta staterna, 94524-4110
- Mount Diablo Medical Center
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Fresno, California, Förenta staterna, 93720
- California Cancer Center
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Fresno, California, Förenta staterna, 93720
- Saint Agnes Cancer Center
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Greenbrae, California, Förenta staterna, 94904
- Sutter Health Western Division Cancer Research Group
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Loma Linda, California, Förenta staterna, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Förenta staterna, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Förenta staterna, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Förenta staterna, 90095-1714
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Förenta staterna, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Förenta staterna, 91105
- Huntington Cancer Center at Huntington Hospital
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Pomona, California, Förenta staterna, 91767
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
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Sacramento, California, Förenta staterna, 95816
- Radiation Oncology Centers - Sacramento
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San Diego, California, Förenta staterna, 92134-3202
- Naval Medical Center - San Diego
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San Diego, California, Förenta staterna, 92101
- Radiation Medical Group, Incorporated
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San Francisco, California, Förenta staterna, 94115
- UCSF Comprehensive Cancer Center
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San Jose, California, Förenta staterna, 95128
- O'Connor Hospital
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Santa Rosa, California, Förenta staterna, 95403
- CCOP - Santa Rosa Memorial Hospital
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Stanford, California, Förenta staterna, 94305-5408
- Stanford Cancer Center at Stanford University Medical Center
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Torrance, California, Förenta staterna, 90505
- Torrance Memorial Medical Center
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Travis Air Force Base, California, Förenta staterna, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Förenta staterna, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Denver, Colorado, Förenta staterna, 80224
- CCOP - Colorado Cancer Research Program, Incorporated
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Grand Junction, Colorado, Förenta staterna, 81502-1628
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06511
- Hospital of St. Raphael
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New Haven, Connecticut, Förenta staterna, 06520-8040
- Yale Comprehensive Cancer Center
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Delaware
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Newark, Delaware, Förenta staterna, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20016
- Sibley Memorial Hospital
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Florida
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Daytona Beach, Florida, Förenta staterna, 32114
- Halifax Medical Center
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Fort Myers, Florida, Förenta staterna, 33901-8082
- 21st Century Oncology - Fort Myers
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Gainesville, Florida, Förenta staterna, 32610-0385
- Shands Cancer Center at the University of Florida Health Science Center
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic - Jacksonville
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Jacksonville, Florida, Förenta staterna, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, Förenta staterna, 32901-3276
- Holmes Regional Medical Center
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Miami, Florida, Förenta staterna, 33176-2197
- Baptist Hospital of Miami
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Miami, Florida, Förenta staterna, 33136
- University of Miami Sylvester Cancer Center
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Miami Beach, Florida, Förenta staterna, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Förenta staterna, 32806-2134
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Förenta staterna, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Förenta staterna, 32401
- Bay Medical Center
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Sarasota, Florida, Förenta staterna, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Förenta staterna, 32308
- Tallahassee Memorial Hospital
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Tampa, Florida, Förenta staterna, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Winship Cancer Institute of Emory University
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Atlanta, Georgia, Förenta staterna, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Förenta staterna, 31901
- Medical Center/John B. Amos Community Cancer Center
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Decatur, Georgia, Förenta staterna, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Rome, Georgia, Förenta staterna, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- MBCCOP - Hawaii
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Illinois
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Arlington Heights, Illinois, Förenta staterna, 60005
- Northwest Community Hospital
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Chicago, Illinois, Förenta staterna, 60611
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Decatur, Illinois, Förenta staterna, 62526
- CCOP - Central Illinois
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Downers Grove, Illinois, Förenta staterna, 60515
- Cancer Care Center at Advocate Good Samaritan Hospital
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Harvey, Illinois, Förenta staterna, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Förenta staterna, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Park Ridge, Illinois, Förenta staterna, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61602
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Förenta staterna, 61602
- CCOP - Scott and White Hospital
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Urbana, Illinois, Förenta staterna, 61801
- CCOP - Carle Cancer Center
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Indiana
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Anderson, Indiana, Förenta staterna, 46016
- St. John's Cancer Center at St. John's Medical Center
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Bloomington, Indiana, Förenta staterna, 47402
- Bloomington Hospital
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Indianapolis, Indiana, Förenta staterna, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, Förenta staterna, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Förenta staterna, 46206-1367
- Methodist Cancer Center at Methodist Hospital
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Indianapolis, Indiana, Förenta staterna, 46219
- Community Regional Cancer Care
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Muncie, Indiana, Förenta staterna, 47303-3499
- Ball Memorial Hospital Cancer Center
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South Bend, Indiana, Förenta staterna, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Cedar Rapids, Iowa, Förenta staterna, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Förenta staterna, 50309-1016
- CCOP - Iowa Oncology Research Association
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Dubuque, Iowa, Förenta staterna, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Sioux City, Iowa, Förenta staterna, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Förenta staterna, 67214-3882
- CCOP - Wichita
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Kentucky
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Edgewood, Kentucky, Förenta staterna, 41017
- St. Elizabeth Medical Center
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Lexington, Kentucky, Förenta staterna, 40503
- Central Baptist Hospital
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Lexington, Kentucky, Förenta staterna, 40536-0293
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Förenta staterna, 40202
- James Graham Brown Cancer Center at University of Louisville
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Louisville, Kentucky, Förenta staterna, 40215
- Louisville Radiation Oncology Center at Caritas Regional Cancer Center
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Madisonville, Kentucky, Förenta staterna, 42431
- Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, Förenta staterna, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Förenta staterna, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Förenta staterna, 70112-2699
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Portland, Maine, Förenta staterna, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, Förenta staterna, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Förenta staterna, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Förenta staterna, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Förenta staterna, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Förenta staterna, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Förenta staterna, 21215-1290
- Harbor Hospital Center
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Baltimore, Maryland, Förenta staterna, 21229
- St. Agnes Cancer Center
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Salisbury, Maryland, Förenta staterna, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Förenta staterna, 02118
- Cancer Research Center at Boston Medical Center
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Boston, Massachusetts, Förenta staterna, 02111
- TUFTS - New England Medical Center
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Boston, Massachusetts, Förenta staterna, 02114
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Hyannis, Massachusetts, Förenta staterna, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Förenta staterna, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Peabody, Massachusetts, Förenta staterna, 01960
- NSMC Cancer Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Förenta staterna, 48109-0010
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Förenta staterna, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Förenta staterna, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Förenta staterna, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Förenta staterna, 49855
- Marquette General Hospital
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Midland, Michigan, Förenta staterna, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Förenta staterna, 48073
- William Beaumont Hospital - Royal Oak
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Royal Oak, Michigan, Förenta staterna, 48073-6769
- CCOP - Beaumont
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Troy, Michigan, Förenta staterna, 48085
- William Beaumont Hospital - Troy
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Minnesota
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Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
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Minneapolis, Minnesota, Förenta staterna, 55455
- Fairview University Medical Center - University Campus
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Minneapolis, Minnesota, Förenta staterna, 55417-2399
- Veterans Affairs Medical Center - Minneapolis
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Rochester, Minnesota, Förenta staterna, 55905-0001
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Förenta staterna, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, Förenta staterna, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Förenta staterna, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Förenta staterna, 63110-0250
- St. Louis University Hospital Cancer Center
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Springfield, Missouri, Förenta staterna, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Förenta staterna, 65807
- Cancer Research for the Ozarks
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St. Louis, Missouri, Förenta staterna, 63110
- Siteman Cancer Center
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Förenta staterna, 68114-4199
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
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Omaha, Nebraska, Förenta staterna, 68198-7521
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, Förenta staterna, 89109
- Comprehensive Cancer Centers of Nevada
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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Manchester, New Hampshire, Förenta staterna, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, Förenta staterna, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Förenta staterna, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Förenta staterna, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Förenta staterna, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, Förenta staterna, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Förenta staterna, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, Förenta staterna, 08903
- Cancer Institute of New Jersey
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Newark, New Jersey, Förenta staterna, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Förenta staterna, 08240
- Atlantic City Medical Center
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Princeton, New Jersey, Förenta staterna, 08540
- Medical Center of Princeton
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Ridgewood, New Jersey, Förenta staterna, 07450
- Valley Hospital
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Toms River, New Jersey, Förenta staterna, 08755
- Community Medical Center
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Trenton, New Jersey, Förenta staterna, 08629
- Fox Chase Cancer Center at St. Francis Medical Center
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Warren, New Jersey, Förenta staterna, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, Förenta staterna, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, Förenta staterna, 10466
- MBCCOP-Our Lady of Mercy Cancer Center
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Brooklyn, New York, Förenta staterna, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Förenta staterna, 11215
- New York Methodist Hospital
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Buffalo, New York, Förenta staterna, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, Förenta staterna, 14432
- Finger Lakes Radiation Oncology Center
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East Syracuse, New York, Förenta staterna, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Manhasset, New York, Förenta staterna, 11030
- CCOP - North Shore University Hospital
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New York, New York, Förenta staterna, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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New York, New York, Förenta staterna, 10003
- Beth Israel Medical Center - Philipps Ambulatory Care Center
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Plattsburgh, New York, Förenta staterna, 12901-1490
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Förenta staterna, 12601
- Vassar Brothers Medical Center
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Rochester, New York, Förenta staterna, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Yonkers, New York, Förenta staterna, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, Förenta staterna, 28025
- Batte Cancer Center at Northeast Medical Center
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Greenville, North Carolina, Förenta staterna, 27835-6028
- Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Förenta staterna, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501-5505
- Medcenter One Health System
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Fargo, North Dakota, Förenta staterna, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, Förenta staterna, 58201
- Altru Cancer Center
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Minot, North Dakota, Förenta staterna, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, Förenta staterna, 44302
- Akron General Medical Center
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Akron, Ohio, Förenta staterna, 44304
- Akron City Hospital
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Cincinnati, Ohio, Förenta staterna, 45219
- Cancer Center at Christ Hospital
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Cincinnati, Ohio, Förenta staterna, 45219
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, Förenta staterna, 44106-5065
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
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Columbus, Ohio, Förenta staterna, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Förenta staterna, 43206
- CCOP - Columbus
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Dayton, Ohio, Förenta staterna, 45429
- CCOP - Dayton
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Parma, Ohio, Förenta staterna, 44129
- Parma Community General Hospital
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Toledo, Ohio, Förenta staterna, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Oklahoma University Medical Center
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Oklahoma City, Oklahoma, Förenta staterna, 73102
- Frank C. Love Cancer Institute at St. Anthony Hospital
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Tulsa, Oklahoma, Förenta staterna, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74104
- St. John Health System
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Oregon
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Portland, Oregon, Förenta staterna, 97225
- CCOP - Columbia River Oncology Program
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Pennsylvania
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Abington, Pennsylvania, Förenta staterna, 19001
- Abington Memorial Hospital
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Allentown, Pennsylvania, Förenta staterna, 18105
- John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
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Bethlehem, Pennsylvania, Förenta staterna, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, Förenta staterna, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Danville, Pennsylvania, Förenta staterna, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Förenta staterna, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, Förenta staterna, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Förenta staterna, 18301
- Dale and Frances Hughes Cancer Center
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Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, Förenta staterna, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Förenta staterna, 19141-3098
- Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Abramson Cancer Center at University of Pennsylvania Medical Center
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Förenta staterna, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Förenta staterna, 15219
- Mercy Hospital of Pittsburgh
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Pittsburgh, Pennsylvania, Förenta staterna, 15236
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Reading, Pennsylvania, Förenta staterna, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Förenta staterna, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Förenta staterna, 18764-0001
- Wilkes-Barre General Hospital
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Wynnewood, Pennsylvania, Förenta staterna, 19096
- CCOP - MainLine Health
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York, Pennsylvania, Förenta staterna, 17403
- Wellspan Health - York Cancer Center
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02908-4735
- Roger Williams Medical Center
-
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Förenta staterna, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Förenta staterna, 57104
- CCOP - Sioux Community Cancer Consortium
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Tennessee
-
Jackson, Tennessee, Förenta staterna, 38301
- West Tennessee Cancer Center at Jackson-Madison County General Hospital
-
Nashville, Tennessee, Förenta staterna, 37232-5671
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
-
-
Texas
-
Amarillo, Texas, Förenta staterna, 79106
- Harrington Cancer Center
-
Arlington, Texas, Förenta staterna, 76012
- Arlington Cancer Center
-
Galveston, Texas, Förenta staterna, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Förenta staterna, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Förenta staterna, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Förenta staterna, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Förenta staterna, 77504
- Bayshore Medical Center
-
San Antonio, Texas, Förenta staterna, 78284-7811
- University of Texas Health Science Center at San Antonio
-
-
Utah
-
Murray, Utah, Förenta staterna, 84107
- Cottonwood Hospital Medical Center
-
Provo, Utah, Förenta staterna, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Förenta staterna, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Förenta staterna, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Förenta staterna, 84143
- LDS Hospital
-
-
Vermont
-
Bennington, Vermont, Förenta staterna, 05201
- Green Mountain Oncology Group
-
Burlington, Vermont, Förenta staterna, 05405-0075
- Vermont Cancer Center at University of Vermont
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Förenta staterna, 22801
- RMH Regional Cancer Center
-
Portsmouth, Virginia, Förenta staterna, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Förenta staterna, 23226
- Bon Secours - St. Mary's Hospital
-
Richmond, Virginia, Förenta staterna, 23298-0124
- Massey Cancer Center at Virginia Commonwealth University
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98195-6043
- University Cancer Center at University of Washington Medical Center
-
Seattle, Washington, Förenta staterna, 98111
- Cancer Institute at Virginia Mason Medical Center
-
Spokane, Washington, Förenta staterna, 99204
- Deaconess Medical Center
-
Yakima, Washington, Förenta staterna, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Förenta staterna, 26003
- Schiffler Cancer Center at Wheeling Hospital
-
-
Wisconsin
-
Green Bay, Wisconsin, Förenta staterna, 54307-3508
- St. Vincent Hospital
-
Green Bay, Wisconsin, Förenta staterna, 54307-3453
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
La Crosse, Wisconsin, Förenta staterna, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Förenta staterna, 53705
- Veterans Affairs Medical Center - Madison
-
Madison, Wisconsin, Förenta staterna, 53713
- Southern Wisconsin Radiotherapy Center
-
Madison, Wisconsin, Förenta staterna, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Clinic
-
Marshfield, Wisconsin, Förenta staterna, 54449
- CCOP - Marshfield Clinic Research Foundation
-
Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Förenta staterna, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, Förenta staterna, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, Förenta staterna, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin Cancer Center
-
Racine, Wisconsin, Förenta staterna, 53405
- All Saints Cancer Center at All Saints Healthcare
-
Waukesha, Wisconsin, Förenta staterna, 53188
- Waukesha Memorial Hospital Regional Cancer Center
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 4N2
- Tom Baker Cancer Center - Calgary
-
Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
-
-
New Brunswick
-
Moncton, New Brunswick, Kanada, E1C 8X3
- Doctor Leon Richard Oncology Centre
-
Saint John, New Brunswick, Kanada, E2L 4L2
- Saint John Regional Hospital
-
-
Newfoundland and Labrador
-
St. Johns, Newfoundland and Labrador, Kanada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 1V7
- Nova Scotia Cancer Centre
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
-
Kingston, Ontario, Kanada, K7L 5P9
- Kingston Regional Cancer Centre
-
London, Ontario, Kanada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
-
Ottawa, Ontario, Kanada, K1H 1C4
- Ottawa Regional Cancer Centre
-
Sudbury, Ontario, Kanada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre at Regional Hospital of Sudbury Regional Hospital
-
Thunder Bay, Ontario, Kanada, P7B 6V4
- Northwestern Ontario Regional Cancer Care
-
Toronto, Ontario, Kanada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
-
Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
-
-
Quebec
-
Fleurimont, Quebec, Kanada, J1H 5N4
- CHUS-Hopital Fleurimont
-
Montreal, Quebec, Kanada, H2W 1S6
- McGill University
-
Montreal, Quebec, Kanada, H2L 4MI
- Centre Hospitalier de l'Université de Montréal
-
Quebec City, Quebec, Kanada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: preooperative chemo followed by surgery
carboplatin paclitaxel conventional surgery
|
|
|
Aktiv komparator: Surgery alone
conventional surgery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Corey J. Langer, MD, Fox Chase Cancer Center
- Studiestol: Joseph A. Treat, MD, Fox Chase Cancer Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 1999
Primärt slutförande (Faktisk)
1 maj 2005
Avslutad studie (Faktisk)
1 november 2012
Studieregistreringsdatum
Först inskickad
1 november 1999
Först inskickad som uppfyllde QC-kriterierna
26 januari 2003
Första postat (Uppskatta)
27 januari 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
31 januari 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 januari 2013
Senast verifierad
1 januari 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Karboplatin
- Paklitaxel
Andra studie-ID-nummer
- CDR0000067223
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
- S9900 (Annan identifierare: NCCTG)
- RTOG-L0015 (Annan identifierare: RTOG)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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