Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
14. november 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
105
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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'Université de Montréal
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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, Forenede Stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Forenede Stater, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Forenede Stater, 35807
- Huntsville Hospital System
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, Forenede Stater, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Forenede Stater, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, Forenede Stater, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Forenede Stater, 93720
- Saint Agnes Cancer Center
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Fresno, California, Forenede Stater, 93729-5100
- California Cancer Center
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Greenbrae, California, Forenede Stater, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forenede Stater, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Forenede Stater, 91105
- Huntington Cancer Center
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Pomona, California, Forenede Stater, 91767
- Robert and Beverly Lewis Family Cancer Care Center
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Sacramento, California, Forenede Stater, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Forenede Stater, 92101
- Radiation Medical Group, Inc.
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San Francisco, California, Forenede Stater, 94143-0128
- UCSF Comprehensive Cancer Center
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San Jose, California, Forenede Stater, 95128
- O'Connor Hospital
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Forenede Stater, 80010
- University of Colorado Cancer Center
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Grand Junction, Colorado, Forenede Stater, 81502-1628
- Saint Mary's Hospital and Medical Center
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
- Hospital of St. Raphael
-
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Delaware
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Wilmington, Delaware, Forenede Stater, 19899
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, Forenede Stater, 32610-0385
- University of Florida Health Science Center
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Jacksonville, Florida, Forenede Stater, 32207
- Florida Radiation Oncology Group
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Melbourne, Florida, Forenede Stater, 32901-3276
- Health First Holmes Regional Medical Center
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Miami, Florida, Forenede Stater, 33136
- Sylvester Cancer Center, University of Miami
-
Miami, Florida, Forenede Stater, 33125
- Veterans Affairs Medical Center - Miami
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Miami, Florida, Forenede Stater, 33256-2110
- Baptist Hospital of Miami
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Forenede Stater, 32806-2134
- MD Anderson Cancer Center Orlando
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Panama City, Florida, Forenede Stater, 32405-4587
- Gulf Coast Cancer Treatment Center
-
Panama City, Florida, Forenede Stater, 32401
- Bay Medical Center
-
Sarasota, Florida, Forenede Stater, 34233
- Sarasota Radiation and Medical Oncology Center
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, Forenede Stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Forenede Stater, 31901
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, Forenede Stater, 30165
- Regional Radiation Oncology Center at Rome
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
- Northwest Community Hospital
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Harvey, Illinois, Forenede Stater, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Forenede Stater, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
- St. John's Medical Center
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Bloomington, Indiana, Forenede Stater, 47402
- Bloomington Hospital
-
Indianapolis, Indiana, Forenede Stater, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Forenede Stater, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, Forenede Stater, 46219
- Regional Cancer Center
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Muncie, Indiana, Forenede Stater, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, Forenede Stater, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Forenede Stater, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, Forenede Stater, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, Forenede Stater, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Forenede Stater, 70112-2699
- Tulane University School of Medicine
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Maine
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Portland, Maine, Forenede Stater, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forenede Stater, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Forenede Stater, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Forenede Stater, 21215-1290
- Harbor Hospital Center
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Salisbury, Maryland, Forenede Stater, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
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Hyannis, Massachusetts, Forenede Stater, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Forenede Stater, 49855
- Marquette General Hospital
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Midland, Michigan, Forenede Stater, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
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Troy, Michigan, Forenede Stater, 48098
- William Beaumont Hospital - Troy
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Forenede Stater, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Forenede Stater, 68114
- Methodist Hospital Cancer Center - Omaha
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Omaha, Nebraska, Forenede Stater, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Forenede Stater, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, Forenede Stater, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Forenede Stater, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Forenede Stater, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Forenede Stater, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, Forenede Stater, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, Forenede Stater, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, Forenede Stater, 38103-2807
- Cancer Institute Of New Jersey
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Forenede Stater, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, Forenede Stater, 07450
- Valley Hospital
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Toms River, New Jersey, Forenede Stater, 08755
- Community Medical Center
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Trenton, New Jersey, Forenede Stater, 08629
- St. Francis Medical Center
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Warren, New Jersey, Forenede Stater, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, Forenede Stater, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Forenede Stater, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, Forenede Stater, 11215
- New York Methodist Hospital
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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Clifton Springs, New York, Forenede Stater, 14432
- Finger Lakes Radiation Oncology Center
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Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Forenede Stater, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, Forenede Stater, 12601
- Vassar Brothers Medical Center
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center
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Syracuse, New York, Forenede Stater, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, Forenede Stater, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Concord, North Carolina, Forenede Stater, 28025
- Northeast Medical Center
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Greenville, North Carolina, Forenede Stater, 27858-4354
- East Carolina University School of Medicine
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Winston-Salem, North Carolina, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Forenede Stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, Forenede Stater, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, Forenede Stater, 44302
- Akron General Medical Center
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Akron, Ohio, Forenede Stater, 44304
- Akron City Hospital
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Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital
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Cincinnati, Ohio, Forenede Stater, 45267-0502
- Barrett Cancer Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals of Cleveland
-
Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
-
Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital
-
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Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forenede Stater, 73101
- St. Anthony Hospital
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Tulsa, Oklahoma, Forenede Stater, 74136
- CCOP - Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74104
- St. John Health System
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Program
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18105
- Lehigh Valley Hospital
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's Hospital Cancer Center
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Danville, Pennsylvania, Forenede Stater, 17822-2001
- Geisinger Medical Center
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Darby, Pennsylvania, Forenede Stater, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, Forenede Stater, 19026
- Delaware County Memorial Hospital
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Pocono Cancer Center
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19141-3098
- Albert Einstein Cancer Center
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213-3489
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, Forenede Stater, 15219
- Mercy Hospital of Pittsburgh
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Reading, Pennsylvania, Forenede Stater, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Forenede Stater, 18501
- Mercy Hospital Cancer Center - Scranton
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Wilkes-Barre, Pennsylvania, Forenede Stater, 18764
- Wilkes Barre General Hospital
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York, Pennsylvania, Forenede Stater, 17403
- York Cancer Center
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02908-4735
- Roger Williams Medical Center/BUSM
-
-
South Carolina
-
Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
-
-
Tennessee
-
Jackson, Tennessee, Forenede Stater, 38301-3956
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee Cancer Institute
-
Nashville, Tennessee, Forenede Stater, 37232-5671
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
-
Galveston, Texas, Forenede Stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forenede Stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Forenede Stater, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Forenede Stater, 77504
- Bayshore Medical Center
-
-
Utah
-
Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Forenede Stater, 84143
- Latter Day Saints Hospital
-
-
Vermont
-
Burlington, Vermont, Forenede Stater, 05405-0075
- Vermont Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Forenede Stater, 22801
- RMH Regional Cancer Center
-
Portsmouth, Virginia, Forenede Stater, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Forenede Stater, 23226
- Bon Secours - St. Mary's Hospital
-
Richmond, Virginia, Forenede Stater, 23298-0058
- Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Forenede Stater, 99204
- Deaconess Medical Center
-
Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Forenede Stater, 26003
- Schiffler Cancer Center
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Foundation
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Forenede Stater, 53713
- Southern Wisconsin Radiotherapy Center
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic
-
Menomonee Falls, Wisconsin, Forenede Stater, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
-
Racine, Wisconsin, Forenede Stater, 53405
- All Saints Cancer Center
-
Waukesha, Wisconsin, Forenede Stater, 53188
- Waukesha Memorial Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall Survival
Tidsramme: From registration to 1 year
|
From registration to 1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Disease-free Survival
Tidsramme: From registration to 1 year
|
From registration to 1 year
|
|
Grade 4-5 toxicity
Tidsramme: 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)
Tidsramme: From registration to last follow-up.
|
From registration to last follow-up.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Corey J. Langer, MD, Fox Chase Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2000
Primær færdiggørelse (Faktiske)
1. november 2004
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
6. april 2000
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- tilbagevendende metastatisk planehalskræft med okkult primær
- metastatisk pladecellekræft med okkult primært pladecellekræft
- stadium III planocellulært karcinom i læben og mundhulen
- tilbagevendende pladecellekarcinom i læben og mundhulen
- stadium III planocellulært karcinom i oropharynx
- tilbagevendende pladecellekarcinom i oropharynx
- stadium III planocellulært karcinom i hypopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- stadium III planocellulært karcinom i strubehovedet
- tilbagevendende pladecellekarcinom i strubehovedet
- stadium III planocellulært karcinom i paranasale sinus og næsehulen
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
- fase I planocellulært karcinom i læben og mundhulen
- fase II planocellulært karcinom i læben og mundhulen
- fase I planocellulært karcinom i paranasale sinus og næsehulen
- stadium II planocellulært karcinom i paranasale sinus og næsehulen
- stadium I planocellulært karcinom i hypopharynx
- fase I planocellulært karcinom i strubehovedet
- stadium I planocellulært karcinom i oropharynx
- fase II planocellulært karcinom i hypopharynx
- fase II planocellulært karcinom i strubehovedet
- fase II planocellulært karcinom i oropharynx
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-9911
- CDR0000067705
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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