Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
14 november 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
105
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Newfoundland Cancer Treatment and Research Foundation
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H2L 4MI
- Centre Hospitalier de l'Universite de Montreal
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Quebec City, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Verenigde Staten, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Verenigde Staten, 35807
- Huntsville Hospital System
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Mobile, Alabama, Verenigde Staten, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Verenigde Staten, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Verenigde Staten, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, Verenigde Staten, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Verenigde Staten, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Verenigde Staten, 93720
- Saint Agnes Cancer Center
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Fresno, California, Verenigde Staten, 93729-5100
- California Cancer Center
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Greenbrae, California, Verenigde Staten, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, Verenigde Staten, 92354
- Loma Linda University Medical Center
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Long Beach, California, Verenigde Staten, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Verenigde Staten, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Verenigde Staten, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Verenigde Staten, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Verenigde Staten, 91105
- Huntington Cancer Center
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Pomona, California, Verenigde Staten, 91767
- Robert and Beverly Lewis Family Cancer Care Center
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Sacramento, California, Verenigde Staten, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Verenigde Staten, 92101
- Radiation Medical Group, Inc.
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San Francisco, California, Verenigde Staten, 94143-0128
- UCSF Comprehensive Cancer Center
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San Jose, California, Verenigde Staten, 95128
- O'Connor Hospital
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Santa Rosa, California, Verenigde Staten, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Verenigde Staten, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Verenigde Staten, 80010
- University of Colorado Cancer Center
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Grand Junction, Colorado, Verenigde Staten, 81502-1628
- Saint Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06511
- Hospital of St. Raphael
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Delaware
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Wilmington, Delaware, Verenigde Staten, 19899
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, Verenigde Staten, 32610-0385
- University of Florida Health Science Center
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Jacksonville, Florida, Verenigde Staten, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, Verenigde Staten, 32901-3276
- Health First Holmes Regional Medical Center
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Miami, Florida, Verenigde Staten, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, Verenigde Staten, 33125
- Veterans Affairs Medical Center - Miami
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Miami, Florida, Verenigde Staten, 33256-2110
- Baptist Hospital of Miami
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Miami Beach, Florida, Verenigde Staten, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Verenigde Staten, 32806-2134
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Verenigde Staten, 32405-4587
- Gulf Coast Cancer Treatment Center
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Panama City, Florida, Verenigde Staten, 32401
- Bay Medical Center
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Sarasota, Florida, Verenigde Staten, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Verenigde Staten, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, Verenigde Staten, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Verenigde Staten, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Verenigde Staten, 31901
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, Verenigde Staten, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- MBCCOP - Hawaii
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Illinois
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Arlington Heights, Illinois, Verenigde Staten, 60005
- Northwest Community Hospital
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern Memorial Hospital
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Decatur, Illinois, Verenigde Staten, 62526
- CCOP - Central Illinois
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Harvey, Illinois, Verenigde Staten, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Verenigde Staten, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Verenigde Staten, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Verenigde Staten, 46016
- St. John's Medical Center
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Bloomington, Indiana, Verenigde Staten, 47402
- Bloomington Hospital
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Indianapolis, Indiana, Verenigde Staten, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Verenigde Staten, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, Verenigde Staten, 46219
- Regional Cancer Center
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Muncie, Indiana, Verenigde Staten, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Verenigde Staten, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, Verenigde Staten, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Verenigde Staten, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, Verenigde Staten, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, Verenigde Staten, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, Verenigde Staten, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Verenigde Staten, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Verenigde Staten, 70112-2699
- Tulane University School of Medicine
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Maine
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Portland, Maine, Verenigde Staten, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, Verenigde Staten, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Verenigde Staten, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Verenigde Staten, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Verenigde Staten, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Verenigde Staten, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Verenigde Staten, 21215-1290
- Harbor Hospital Center
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Salisbury, Maryland, Verenigde Staten, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Dana-Farber Cancer Institute
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Hyannis, Massachusetts, Verenigde Staten, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Verenigde Staten, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Hospital
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Detroit, Michigan, Verenigde Staten, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Flint, Michigan, Verenigde Staten, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Verenigde Staten, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Verenigde Staten, 49855
- Marquette General Hospital
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Midland, Michigan, Verenigde Staten, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Verenigde Staten, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Verenigde Staten, 48073
- William Beaumont Hospital
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Troy, Michigan, Verenigde Staten, 48098
- William Beaumont Hospital - Troy
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, Verenigde Staten, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, Verenigde Staten, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Verenigde Staten, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Verenigde Staten, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Verenigde Staten, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Verenigde Staten, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Verenigde Staten, 68114
- Methodist Hospital Cancer Center - Omaha
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Omaha, Nebraska, Verenigde Staten, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Verenigde Staten, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, Verenigde Staten, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Verenigde Staten, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Verenigde Staten, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Verenigde Staten, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, Verenigde Staten, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Verenigde Staten, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, Verenigde Staten, 38103-2807
- Cancer Institute of New Jersey
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Newark, New Jersey, Verenigde Staten, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Verenigde Staten, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, Verenigde Staten, 07450
- Valley Hospital
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Toms River, New Jersey, Verenigde Staten, 08755
- Community Medical Center
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Trenton, New Jersey, Verenigde Staten, 08629
- St. Francis Medical Center
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Warren, New Jersey, Verenigde Staten, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, Verenigde Staten, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Verenigde Staten, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, Verenigde Staten, 11215
- New York Methodist Hospital
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Buffalo, New York, Verenigde Staten, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, Verenigde Staten, 14432
- Finger Lakes Radiation Oncology Center
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Manhasset, New York, Verenigde Staten, 11030
- CCOP - North Shore University Hospital
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New York, New York, Verenigde Staten, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Verenigde Staten, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Verenigde Staten, 12601
- Vassar Brothers Medical Center
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Rochester, New York, Verenigde Staten, 14642
- James P. Wilmot Cancer Center
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Syracuse, New York, Verenigde Staten, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, Verenigde Staten, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, Verenigde Staten, 28025
- Northeast Medical Center
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Greenville, North Carolina, Verenigde Staten, 27858-4354
- East Carolina University School of Medicine
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Winston-Salem, North Carolina, Verenigde Staten, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Verenigde Staten, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, Verenigde Staten, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, Verenigde Staten, 44302
- Akron General Medical Center
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Akron, Ohio, Verenigde Staten, 44304
- Akron City Hospital
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Cincinnati, Ohio, Verenigde Staten, 45219
- Christ Hospital
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Cincinnati, Ohio, Verenigde Staten, 45267-0502
- Barrett Cancer Center
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Verenigde Staten, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, Verenigde Staten, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Verenigde Staten, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Verenigde Staten, 43206
- CCOP - Columbus
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Dayton, Ohio, Verenigde Staten, 45429
- CCOP - Dayton
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Toledo, Ohio, Verenigde Staten, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Verenigde Staten, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, Verenigde Staten, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74104
- St. John Health System
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Oregon
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Portland, Oregon, Verenigde Staten, 97225
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, Verenigde Staten, 18105
- Lehigh Valley Hospital
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Bethlehem, Pennsylvania, Verenigde Staten, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, Verenigde Staten, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Verenigde Staten, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, Verenigde Staten, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Verenigde Staten, 18301
- Pocono Cancer Center
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Hershey, Pennsylvania, Verenigde Staten, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Verenigde Staten, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Veterans Affairs Medical Center - Philadelphia
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Philadelphia, Pennsylvania, Verenigde Staten, 19104-4283
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Verenigde Staten, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Verenigde Staten, 19141-3098
- Albert Einstein Cancer Center
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Pittsburgh, Pennsylvania, Verenigde Staten, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213-3489
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, Verenigde Staten, 15219
- Mercy Hospital of Pittsburgh
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Reading, Pennsylvania, Verenigde Staten, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Verenigde Staten, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Verenigde Staten, 18764
- Wilkes Barre General Hospital
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York, Pennsylvania, Verenigde Staten, 17403
- York Cancer Center
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02908-4735
- Roger Williams Medical Center/BUSM
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Verenigde Staten, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Verenigde Staten, 57709
- Rapid City Regional Hospital
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Tennessee
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Jackson, Tennessee, Verenigde Staten, 38301-3956
- Jackson-Madison County General Hospital
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Memphis, Tennessee, Verenigde Staten, 38103
- University of Tennessee Cancer Institute
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Nashville, Tennessee, Verenigde Staten, 37232-5671
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Verenigde Staten, 79106
- Harrington Cancer Center
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Galveston, Texas, Verenigde Staten, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Verenigde Staten, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, Verenigde Staten, 78236-5300
- Wilford Hall Medical Center
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Lubbock, Texas, Verenigde Staten, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
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Pasadena, Texas, Verenigde Staten, 77504
- Bayshore Medical Center
-
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Utah
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Saint George, Utah, Verenigde Staten, 84770
- Dixie Regional Medical Center
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Salt Lake City, Utah, Verenigde Staten, 84132
- University of Utah Health Sciences Center
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Salt Lake City, Utah, Verenigde Staten, 84143
- Latter Day Saints Hospital
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Vermont
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Burlington, Vermont, Verenigde Staten, 05405-0075
- Vermont Cancer Center
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22908
- Cancer Center at the University of Virginia
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Harrisonburg, Virginia, Verenigde Staten, 22801
- RMH Regional Cancer Center
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Portsmouth, Virginia, Verenigde Staten, 23708-2197
- Naval Medical Center, Portsmouth
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Richmond, Virginia, Verenigde Staten, 23226
- Bon Secours - St. Mary's Hospital
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Richmond, Virginia, Verenigde Staten, 23298-0058
- Massey Cancer Center
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Washington
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Seattle, Washington, Verenigde Staten, 98111
- Virginia Mason Medical Center
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Spokane, Washington, Verenigde Staten, 99204
- Deaconess Medical Center
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Yakima, Washington, Verenigde Staten, 98902
- Yakima Valley Memorial Hospital
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West Virginia
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Wheeling, West Virginia, Verenigde Staten, 26003
- Schiffler Cancer Center
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Wisconsin
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Green Bay, Wisconsin, Verenigde Staten, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Verenigde Staten, 54307-3508
- St. Vincent Hospital
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La Crosse, Wisconsin, Verenigde Staten, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Verenigde Staten, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, Verenigde Staten, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, Verenigde Staten, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, Verenigde Staten, 53215
- St. Luke's Medical Center
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Milwaukee, Wisconsin, Verenigde Staten, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Racine, Wisconsin, Verenigde Staten, 53405
- All Saints Cancer Center
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Waukesha, Wisconsin, Verenigde Staten, 53188
- Waukesha Memorial Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
DISEASE CHARACTERISTICS:
Histologically 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Overall Survival
Tijdsspanne: From registration to 1 year
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From registration to 1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Disease-free Survival
Tijdsspanne: From registration to 1 year
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From registration to 1 year
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Grade 4-5 toxicity
Tijdsspanne: From one year after the start of radiation therapy to last follow-up.
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From one year after the start of radiation therapy to last follow-up.
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Pattern of failure (local-regional, distant, new primary, death)
Tijdsspanne: From registration to last follow-up.
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From registration to last follow-up.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Corey J. Langer, MD, Fox Chase Cancer Center
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2000
Primaire voltooiing (Werkelijk)
1 november 2004
Studie voltooiing (Werkelijk)
1 november 2013
Studieregistratiedata
Eerst ingediend
6 april 2000
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2003
Eerst geplaatst (Schatting)
27 januari 2003
Updates van studierecords
Laatste update geplaatst (Schatting)
17 november 2015
Laatste update ingediend die voldeed aan QC-criteria
14 november 2015
Laatst geverifieerd
1 november 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- recidiverende uitgezaaide plaveiselhalskanker met occult primair
- gemetastaseerde plaveiselhalskanker met occult primair plaveiselcelcarcinoom
- stadium III plaveiselcelcarcinoom van de lip en mondholte
- recidiverend plaveiselcelcarcinoom van de lip en mondholte
- stadium III plaveiselcelcarcinoom van de orofarynx
- recidiverend plaveiselcelcarcinoom van de orofarynx
- stadium III plaveiselcelcarcinoom van de hypofarynx
- recidiverend plaveiselcelcarcinoom van de hypofarynx
- stadium III plaveiselcelcarcinoom van het strottenhoofd
- recidiverend plaveiselcelcarcinoom van het strottenhoofd
- stadium III plaveiselcelcarcinoom van de neusbijholten en de neusholte
- recidiverend plaveiselcelcarcinoom van de neusbijholten en de neusholte
- stadium I plaveiselcelcarcinoom van de lip en mondholte
- stadium II plaveiselcelcarcinoom van de lip en mondholte
- stadium I plaveiselcelcarcinoom van de neusbijholte en de neusholte
- stadium II plaveiselcelcarcinoom van de neusbijholten en de neusholte
- stadium I plaveiselcelcarcinoom van de hypofarynx
- stadium I plaveiselcelcarcinoom van het strottenhoofd
- stadium I plaveiselcelcarcinoom van de orofarynx
- stadium II plaveiselcelcarcinoom van de hypofarynx
- stadium II plaveiselcelcarcinoom van het strottenhoofd
- stadium II plaveiselcelcarcinoom van de orofarynx
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RTOG-9911
- CDR0000067705
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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