Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
14 de noviembre de 2015 actualizado por: Radiation Therapy Oncology Group
Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the median, one-year, and long-term (defined as two-year) disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and filgrastim (G-CSF) combined with radiotherapy.
- Determine the rates of acute and late toxic effects of this regimen in these patients.
- Determine the pattern of disease progression in patients treated with this regimen.
OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim (G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who initially respond to therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment field) may undergo surgical resection.
Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.
Tipo de estudio
Intervencionista
Inscripción (Actual)
105
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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New Brunswick
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Saint John, New Brunswick, Canadá, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canadá, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canadá, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, Canadá, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, Canadá, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Canadá, K1H 1C4
- Ottawa Regional Cancer Centre
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Sudbury, Ontario, Canadá, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canadá, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canadá, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canadá, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Fleurimont, Quebec, Canadá, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, Canadá, H2W 1S6
- McGill University
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Montreal, Quebec, Canadá, H2L 4MI
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, Canadá, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Estados Unidos, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Estados Unidos, 35807
- Huntsville Hospital System
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Mobile, Alabama, Estados Unidos, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Estados Unidos, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Estados Unidos, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, Estados Unidos, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Estados Unidos, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Estados Unidos, 93720
- Saint Agnes Cancer Center
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Fresno, California, Estados Unidos, 93729-5100
- California Cancer Center
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Greenbrae, California, Estados Unidos, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Medical Center
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Long Beach, California, Estados Unidos, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Estados Unidos, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Estados Unidos, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Estados Unidos, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Estados Unidos, 91105
- Huntington Cancer Center
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Pomona, California, Estados Unidos, 91767
- Robert and Beverly Lewis Family Cancer Care Center
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Sacramento, California, Estados Unidos, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Estados Unidos, 92101
- Radiation Medical Group, Inc.
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San Francisco, California, Estados Unidos, 94143-0128
- UCSF Comprehensive Cancer Center
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San Jose, California, Estados Unidos, 95128
- O'Connor Hospital
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Santa Rosa, California, Estados Unidos, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Estados Unidos, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Estados Unidos, 80010
- University of Colorado Cancer Center
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Grand Junction, Colorado, Estados Unidos, 81502-1628
- Saint Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- Hospital of St. Raphael
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Delaware
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Wilmington, Delaware, Estados Unidos, 19899
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, Estados Unidos, 32610-0385
- University of Florida Health Science Center
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Jacksonville, Florida, Estados Unidos, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, Estados Unidos, 32901-3276
- Health First Holmes Regional Medical Center
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Miami, Florida, Estados Unidos, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Estados Unidos, 33125
- Veterans Affairs Medical Center - Miami
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Miami, Florida, Estados Unidos, 33256-2110
- Baptist Hospital of Miami
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Miami Beach, Florida, Estados Unidos, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Estados Unidos, 32806-2134
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Estados Unidos, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Estados Unidos, 32401
- Bay Medical Center
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Sarasota, Florida, Estados Unidos, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Estados Unidos, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, Estados Unidos, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Estados Unidos, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Estados Unidos, 31901
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, Estados Unidos, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- MBCCOP - Hawaii
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Illinois
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Arlington Heights, Illinois, Estados Unidos, 60005
- Northwest Community Hospital
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Memorial Hospital
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Decatur, Illinois, Estados Unidos, 62526
- CCOP - Central Illinois
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Harvey, Illinois, Estados Unidos, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Estados Unidos, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Estados Unidos, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Estados Unidos, 46016
- St. John's Medical Center
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Bloomington, Indiana, Estados Unidos, 47402
- Bloomington Hospital
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Indianapolis, Indiana, Estados Unidos, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Estados Unidos, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, Estados Unidos, 46219
- Regional Cancer Center
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Muncie, Indiana, Estados Unidos, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Estados Unidos, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, Estados Unidos, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Estados Unidos, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, Estados Unidos, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, Estados Unidos, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, Estados Unidos, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Estados Unidos, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Estados Unidos, 70112-2699
- Tulane University School of Medicine
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Maine
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Portland, Maine, Estados Unidos, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, Estados Unidos, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Estados Unidos, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Estados Unidos, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Estados Unidos, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Estados Unidos, 21215-1290
- Harbor Hospital Center
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Salisbury, Maryland, Estados Unidos, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute
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Hyannis, Massachusetts, Estados Unidos, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0752
- University Of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Flint, Michigan, Estados Unidos, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Estados Unidos, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Estados Unidos, 49855
- Marquette General Hospital
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Midland, Michigan, Estados Unidos, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Estados Unidos, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Estados Unidos, 48073
- William Beaumont Hospital
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Troy, Michigan, Estados Unidos, 48098
- William Beaumont Hospital - Troy
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, Estados Unidos, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Estados Unidos, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Estados Unidos, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Estados Unidos, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Estados Unidos, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, Estados Unidos, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Estados Unidos, 68114
- Methodist Hospital Cancer Center - Omaha
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Omaha, Nebraska, Estados Unidos, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Estados Unidos, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, Estados Unidos, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Estados Unidos, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Estados Unidos, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Estados Unidos, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, Estados Unidos, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Estados Unidos, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, Estados Unidos, 38103-2807
- Cancer Institute Of New Jersey
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Newark, New Jersey, Estados Unidos, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Estados Unidos, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, Estados Unidos, 07450
- Valley Hospital
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Toms River, New Jersey, Estados Unidos, 08755
- Community Medical Center
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Trenton, New Jersey, Estados Unidos, 08629
- St. Francis Medical Center
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Warren, New Jersey, Estados Unidos, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, Estados Unidos, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Estados Unidos, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, Estados Unidos, 11215
- New York Methodist Hospital
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, Estados Unidos, 14432
- Finger Lakes Radiation Oncology Center
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Manhasset, New York, Estados Unidos, 11030
- CCOP - North Shore University Hospital
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Estados Unidos, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Estados Unidos, 12601
- Vassar Brothers Medical Center
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Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center
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Syracuse, New York, Estados Unidos, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, Estados Unidos, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, Estados Unidos, 28025
- Northeast Medical Center
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Greenville, North Carolina, Estados Unidos, 27858-4354
- East Carolina University School of Medicine
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Winston-Salem, North Carolina, Estados Unidos, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, Estados Unidos, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, Estados Unidos, 44302
- Akron General Medical Center
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Akron, Ohio, Estados Unidos, 44304
- Akron City Hospital
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Cincinnati, Ohio, Estados Unidos, 45219
- Christ Hospital
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Cincinnati, Ohio, Estados Unidos, 45267-0502
- Barrett Cancer Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Estados Unidos, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Estados Unidos, 43206
- CCOP - Columbus
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Dayton, Ohio, Estados Unidos, 45429
- CCOP - Dayton
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Toledo, Ohio, Estados Unidos, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Estados Unidos, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, Estados Unidos, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74104
- St. John Health System
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Oregon
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Portland, Oregon, Estados Unidos, 97225
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18105
- LeHigh Valley Hospital
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Bethlehem, Pennsylvania, Estados Unidos, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, Estados Unidos, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Estados Unidos, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, Estados Unidos, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Estados Unidos, 18301
- Pocono Cancer Center
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Estados Unidos, 19141-3098
- Albert Einstein Cancer Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Estados Unidos, 15213-3489
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, Estados Unidos, 15219
- Mercy Hospital of Pittsburgh
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Reading, Pennsylvania, Estados Unidos, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Estados Unidos, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Estados Unidos, 18764
- Wilkes Barre General Hospital
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York, Pennsylvania, Estados Unidos, 17403
- York Cancer Center
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02908-4735
- Roger Williams Medical Center/BUSM
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Estados Unidos, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57709
- Rapid City Regional Hospital
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Tennessee
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Jackson, Tennessee, Estados Unidos, 38301-3956
- Jackson-Madison County General Hospital
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Memphis, Tennessee, Estados Unidos, 38103
- University of Tennessee Cancer Institute
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Nashville, Tennessee, Estados Unidos, 37232-5671
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Harrington Cancer Center
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Galveston, Texas, Estados Unidos, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, Estados Unidos, 78236-5300
- Wilford Hall Medical Center
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Lubbock, Texas, Estados Unidos, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
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Pasadena, Texas, Estados Unidos, 77504
- Bayshore Medical Center
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Utah
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Saint George, Utah, Estados Unidos, 84770
- Dixie Regional Medical Center
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah Health Sciences Center
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Salt Lake City, Utah, Estados Unidos, 84143
- Latter Day Saints Hospital
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Vermont
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Burlington, Vermont, Estados Unidos, 05405-0075
- Vermont Cancer Center
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Cancer Center at the University of Virginia
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Harrisonburg, Virginia, Estados Unidos, 22801
- RMH Regional Cancer Center
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Portsmouth, Virginia, Estados Unidos, 23708-2197
- Naval Medical Center, Portsmouth
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Richmond, Virginia, Estados Unidos, 23226
- Bon Secours - St. Mary's Hospital
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Richmond, Virginia, Estados Unidos, 23298-0058
- Massey Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98111
- Virginia Mason Medical Center
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Spokane, Washington, Estados Unidos, 99204
- Deaconess Medical Center
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Yakima, Washington, Estados Unidos, 98902
- Yakima Valley Memorial Hospital
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West Virginia
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Wheeling, West Virginia, Estados Unidos, 26003
- Schiffler Cancer Center
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Estados Unidos, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, Estados Unidos, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, Estados Unidos, 53215
- St. Luke's Medical Center
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Milwaukee, Wisconsin, Estados Unidos, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Racine, Wisconsin, Estados Unidos, 53405
- All Saints Cancer Center
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Waukesha, Wisconsin, Estados Unidos, 53188
- Waukesha Memorial Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
Histologically proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck
- More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy
- Disease must be confined to the head and neck (above the clavicles)
- No primary SCC of the nasopharynx or salivary gland
- Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume
Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy
- Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded
- Measurable disease
- Ineligible for complete surgical resection
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0 or 1
Life expectancy:
- No other concurrent illness that would limit survival
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 2 times normal*
- Alkaline phosphatase no greater than 2 times normal*
- * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan
Renal:
- Creatinine no greater than 1.5 mg/dL
Other:
- No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer)
- No other concurrent illness that would impair tolerance to therapy
- No grade 2 or worse pre-existing peripheral sensory neuropathy
- No hypersensitivity to E. coli derived products
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy allowed as a component of the primary treatment
- No prior chemotherapy for recurrent disease
- At least 6 months since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 6 months since prior radiotherapy
Surgery:
- See Disease Characteristics
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Radiation (BID) and chemotherapy
Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Overall Survival
Periodo de tiempo: From registration to 1 year
|
From registration to 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Disease-free Survival
Periodo de tiempo: From registration to 1 year
|
From registration to 1 year
|
|
Grade 4-5 toxicity
Periodo de tiempo: From one year after the start of radiation therapy to last follow-up.
|
From one year after the start of radiation therapy to last follow-up.
|
|
Pattern of failure (local-regional, distant, new primary, death)
Periodo de tiempo: From registration to last follow-up.
|
From registration to last follow-up.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Corey J. Langer, MD, Fox Chase Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Langer CJ, Harris J, Horwitz EM, Nicolaou N, Kies M, Curran W, Wong S, Ang K. Phase II study of low-dose paclitaxel and cisplatin in combination with split-course concomitant twice-daily reirradiation in recurrent squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Protocol 9911. J Clin Oncol. 2007 Oct 20;25(30):4800-5. doi: 10.1200/JCO.2006.07.9194.
- Horwitz EM, Harris J, Langer CJ, et al.: Concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): update of RTOG 9911 . [Abstract] J Clin Oncol 23 (Suppl 16): A-5577, 519s, 2005.
- Horwitz EM, Harris J, Langer CJ, et al.: Phase II study of paclitaxel and cisplatin in combination with split course concomitant hyperfractioned re-irradiation in patients with recurrent squamous cell cancer of the head and neck : results of RTOG 99-11. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-119, S72, 2005.
- Langer CJ, Harris J, Horwitz E, et al.: Phase II trial of concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): results of RTOG 9911. [Abstract] J Clin Oncol 22 (Suppl 14): A-5509, 490s, 2004.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2000
Finalización primaria (Actual)
1 de noviembre de 2004
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
6 de abril de 2000
Primero enviado que cumplió con los criterios de control de calidad
26 de enero de 2003
Publicado por primera vez (Estimar)
27 de enero de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
14 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
- Cáncer de cuello escamoso metastásico recurrente con tumor primario oculto
- cáncer de cuello escamoso metastásico con carcinoma de células escamosas primario oculto
- Carcinoma de células escamosas de labio y cavidad oral en estadio III
- Carcinoma recurrente de células escamosas de labio y cavidad oral.
- Carcinoma de células escamosas de orofaringe en estadio III
- carcinoma de células escamosas recurrente de la orofaringe
- Carcinoma epidermoide de hipofaringe en estadio III
- carcinoma de células escamosas recurrente de hipofaringe
- Carcinoma de células escamosas de laringe en estadio III
- carcinoma de células escamosas recurrente de laringe
- Carcinoma de células escamosas en estadio III del seno paranasal y la cavidad nasal
- Carcinoma de células escamosas recurrente del seno paranasal y la cavidad nasal
- Carcinoma epidermoide de labio y cavidad oral en estadio I
- Carcinoma de células escamosas de labio y cavidad oral en estadio II
- Carcinoma epidermoide de seno paranasal y cavidad nasal en estadio I
- Carcinoma de células escamosas de seno paranasal y cavidad nasal en estadio II
- Carcinoma epidermoide de hipofaringe en estadio I
- Carcinoma de células escamosas de laringe en estadio I
- Carcinoma de células escamosas de orofaringe en estadio I
- Carcinoma de células escamosas de hipofaringe en estadio II
- Carcinoma de células escamosas de laringe en estadio II
- Carcinoma de células escamosas de la orofaringe en estadio II
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RTOG-9911
- CDR0000067705
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .