Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
14. november 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
105
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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, Forente stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, Forente stater, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, Forente stater, 35807
- Huntsville Hospital System
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Mobile, Alabama, Forente stater, 36688
- MBCCOP - Gulf Coast
-
Montgomery, Alabama, Forente stater, 36106-3657
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, Forente stater, 35401
- DCH Cancer Treatment Center
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Arizona
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Phoenix, Arizona, Forente stater, 85013
- Foundation for Cancer Research and Education
-
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California
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Concord, California, Forente stater, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, Forente stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Forente stater, 93720
- Saint Agnes Cancer Center
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Fresno, California, Forente stater, 93729-5100
- California Cancer Center
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Greenbrae, California, Forente stater, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, Forente stater, 92354
- Loma Linda University Medical Center
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Long Beach, California, Forente stater, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Forente stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forente stater, 90025-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Forente stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, Forente stater, 91105
- Huntington Cancer Center
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Pomona, California, Forente stater, 91767
- Robert and Beverly Lewis Family Cancer Care Center
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Sacramento, California, Forente stater, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, Forente stater, 92101
- Radiation Medical Group, Inc.
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San Francisco, California, Forente stater, 94143-0128
- UCSF Comprehensive Cancer Center
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San Jose, California, Forente stater, 95128
- O'Connor Hospital
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Santa Rosa, California, Forente stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forente stater, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, Forente stater, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, Forente stater, 80010
- University of Colorado Cancer Center
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Grand Junction, Colorado, Forente stater, 81502-1628
- Saint Mary's Hospital and Medical Center
-
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Connecticut
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New Haven, Connecticut, Forente stater, 06511
- Hospital of St. Raphael
-
-
Delaware
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Wilmington, Delaware, Forente stater, 19899
- CCOP - Christiana Care Health Services
-
-
Florida
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Gainesville, Florida, Forente stater, 32610-0385
- University of Florida Health Science Center
-
Jacksonville, Florida, Forente stater, 32207
- Florida Radiation Oncology Group
-
Melbourne, Florida, Forente stater, 32901-3276
- Health First Holmes Regional Medical Center
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Miami, Florida, Forente stater, 33136
- Sylvester Cancer Center, University of Miami
-
Miami, Florida, Forente stater, 33125
- Veterans Affairs Medical Center - Miami
-
Miami, Florida, Forente stater, 33256-2110
- Baptist Hospital of Miami
-
Miami Beach, Florida, Forente stater, 33140
- CCOP - Mount Sinai Medical Center
-
Orlando, Florida, Forente stater, 32806-2134
- MD Anderson Cancer Center Orlando
-
Panama City, Florida, Forente stater, 32405-4587
- Gulf Coast Cancer Treatment Center
-
Panama City, Florida, Forente stater, 32401
- Bay Medical Center
-
Sarasota, Florida, Forente stater, 34233
- Sarasota Radiation and Medical Oncology Center
-
Tallahassee, Florida, Forente stater, 32308
- Tallahassee Memorial HealthCare
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Tampa, Florida, Forente stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Forente stater, 30342-1701
- CCOP - Atlanta Regional
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Columbus, Georgia, Forente stater, 31901
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, Forente stater, 30165
- Regional Radiation Oncology Center at Rome
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-
Hawaii
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Honolulu, Hawaii, Forente stater, 96813
- MBCCOP - Hawaii
-
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Illinois
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Arlington Heights, Illinois, Forente stater, 60005
- Northwest Community Hospital
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Chicago, Illinois, Forente stater, 60611
- Northwestern Memorial Hospital
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Decatur, Illinois, Forente stater, 62526
- CCOP - Central Illinois
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Harvey, Illinois, Forente stater, 60426
- Ingalls Memorial Hospital
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Maywood, Illinois, Forente stater, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Forente stater, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
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Indiana
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Anderson, Indiana, Forente stater, 46016
- St. John's Medical Center
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Bloomington, Indiana, Forente stater, 47402
- Bloomington Hospital
-
Indianapolis, Indiana, Forente stater, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, Forente stater, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, Forente stater, 46219
- Regional Cancer Center
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Muncie, Indiana, Forente stater, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, Forente stater, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Dubuque, Iowa, Forente stater, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
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Lexington, Kentucky, Forente stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Forente stater, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Forente stater, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, Forente stater, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, Forente stater, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, Forente stater, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Forente stater, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Forente stater, 70112-2699
- Tulane University School of Medicine
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Maine
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Portland, Maine, Forente stater, 04102
- Maine Medical Center
-
-
Maryland
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Annapolis, Maryland, Forente stater, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, Forente stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forente stater, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Forente stater, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
-
Baltimore, Maryland, Forente stater, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, Forente stater, 21215-1290
- Harbor Hospital Center
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Salisbury, Maryland, Forente stater, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
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Hyannis, Massachusetts, Forente stater, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, Forente stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109-0752
- University Of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forente stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forente stater, 48532-3685
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, Forente stater, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, Forente stater, 49855
- Marquette General Hospital
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Midland, Michigan, Forente stater, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, Forente stater, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Forente stater, 48073
- William Beaumont Hospital
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Troy, Michigan, Forente stater, 48098
- William Beaumont Hospital - Troy
-
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
-
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Missouri
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Columbia, Missouri, Forente stater, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, Forente stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forente stater, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Forente stater, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, Forente stater, 65807
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Forente stater, 65807
- Cancer Research for the Ozarks
-
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Montana
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Billings, Montana, Forente stater, 59101
- CCOP - Montana Cancer Consortium
-
-
Nebraska
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Omaha, Nebraska, Forente stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Forente stater, 68114
- Methodist Hospital Cancer Center - Omaha
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Omaha, Nebraska, Forente stater, 68198-7460
- Nebraska Health System
-
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, Forente stater, 03103
- Elliot Regional Cancer Center
-
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New Jersey
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East Orange, New Jersey, Forente stater, 07019
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, Forente stater, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, Forente stater, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, Forente stater, 07740-6395
- Monmouth Medical Center
-
Millville, New Jersey, Forente stater, 08332
- South Jersey Regional Cancer Center
-
Mount Holly, New Jersey, Forente stater, 08060
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
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New Brunswick, New Jersey, Forente stater, 38103-2807
- Cancer Institute Of New Jersey
-
Newark, New Jersey, Forente stater, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, Forente stater, 08240
- Atlantic City Medical Center
-
Ridgewood, New Jersey, Forente stater, 07450
- Valley Hospital
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Toms River, New Jersey, Forente stater, 08755
- Community Medical Center
-
Trenton, New Jersey, Forente stater, 08629
- St. Francis Medical Center
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Warren, New Jersey, Forente stater, 07059
- Associated Radiologists, P.A.
-
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
- Radiation Oncology Associates of Albuquerque
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New York
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Albany, New York, Forente stater, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, Forente stater, 11203
- State University of New York Health Science Center at Brooklyn
-
Brooklyn, New York, Forente stater, 11215
- New York Methodist Hospital
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
-
Clifton Springs, New York, Forente stater, 14432
- Finger Lakes Radiation Oncology Center
-
Manhasset, New York, Forente stater, 11030
- CCOP - North Shore University Hospital
-
New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, Forente stater, 12901
- Champlain Valley Physicians Hospital Medical Center
-
Poughkeepsie, New York, Forente stater, 12601
- Vassar Brothers Medical Center
-
Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center
-
Syracuse, New York, Forente stater, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, Forente stater, 10701
- Riverhill Radiation Oncology
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Concord, North Carolina, Forente stater, 28025
- Northeast Medical Center
-
Greenville, North Carolina, Forente stater, 27858-4354
- East Carolina University School of Medicine
-
Winston-Salem, North Carolina, Forente stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, Forente stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
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Minot, North Dakota, Forente stater, 58701
- Trinity Cancer Care Center
-
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Ohio
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Akron, Ohio, Forente stater, 44302
- Akron General Medical Center
-
Akron, Ohio, Forente stater, 44304
- Akron City Hospital
-
Cincinnati, Ohio, Forente stater, 45219
- Christ Hospital
-
Cincinnati, Ohio, Forente stater, 45267-0502
- Barrett Cancer Center
-
Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forente stater, 44106
- University Hospitals of Cleveland
-
Cleveland, Ohio, Forente stater, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Forente stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
Columbus, Ohio, Forente stater, 43206
- CCOP - Columbus
-
Dayton, Ohio, Forente stater, 45429
- CCOP - Dayton
-
Toledo, Ohio, Forente stater, 43623-3456
- CCOP - Toledo Community Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forente stater, 73101
- St. Anthony Hospital
-
Tulsa, Oklahoma, Forente stater, 74136
- CCOP - Oklahoma
-
Tulsa, Oklahoma, Forente stater, 74104
- St. John Health System
-
-
Oregon
-
Portland, Oregon, Forente stater, 97225
- CCOP - Columbia River Program
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forente stater, 18105
- LeHigh Valley Hospital
-
Bethlehem, Pennsylvania, Forente stater, 18015
- St. Luke's Hospital Cancer Center
-
Danville, Pennsylvania, Forente stater, 17822-2001
- Geisinger Medical Center
-
Darby, Pennsylvania, Forente stater, 19023
- Mercy Fitzgerald Hospital
-
Drexel Hill, Pennsylvania, Forente stater, 19026
- Delaware County Memorial Hospital
-
East Stroudsburg, Pennsylvania, Forente stater, 18301
- Pocono Cancer Center
-
Hershey, Pennsylvania, Forente stater, 17033-0850
- Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, Forente stater, 19104-4283
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, Forente stater, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
-
Philadelphia, Pennsylvania, Forente stater, 19141-3098
- Albert Einstein Cancer Center
-
Pittsburgh, Pennsylvania, Forente stater, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, Forente stater, 15213-3489
- University of Pittsburgh Cancer Institute
-
Pittsburgh, Pennsylvania, Forente stater, 15219
- Mercy Hospital of Pittsburgh
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Reading, Pennsylvania, Forente stater, 19612-6052
- Reading Hospital and Medical Center
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Scranton, Pennsylvania, Forente stater, 18501
- Mercy Hospital Cancer Center - Scranton
-
Wilkes-Barre, Pennsylvania, Forente stater, 18764
- Wilkes Barre General Hospital
-
York, Pennsylvania, Forente stater, 17403
- York Cancer Center
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02908-4735
- Roger Williams Medical Center/BUSM
-
-
South Carolina
-
Greenville, South Carolina, Forente stater, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, Forente stater, 29303
- CCOP - Upstate Carolina
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57709
- Rapid City Regional Hospital
-
-
Tennessee
-
Jackson, Tennessee, Forente stater, 38301-3956
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, Forente stater, 38103
- University of Tennessee Cancer Institute
-
Nashville, Tennessee, Forente stater, 37232-5671
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, Forente stater, 79106
- Harrington Cancer Center
-
Galveston, Texas, Forente stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forente stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forente stater, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Forente stater, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
Pasadena, Texas, Forente stater, 77504
- Bayshore Medical Center
-
-
Utah
-
Saint George, Utah, Forente stater, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, Forente stater, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, Forente stater, 84143
- Latter Day Saints Hospital
-
-
Vermont
-
Burlington, Vermont, Forente stater, 05405-0075
- Vermont Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, Forente stater, 22801
- RMH Regional Cancer Center
-
Portsmouth, Virginia, Forente stater, 23708-2197
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Forente stater, 23226
- Bon Secours - St. Mary's Hospital
-
Richmond, Virginia, Forente stater, 23298-0058
- Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Forente stater, 98111
- Virginia Mason Medical Center
-
Spokane, Washington, Forente stater, 99204
- Deaconess Medical Center
-
Yakima, Washington, Forente stater, 98902
- Yakima Valley Memorial Hospital
-
-
West Virginia
-
Wheeling, West Virginia, Forente stater, 26003
- Schiffler Cancer Center
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forente stater, 54307-3508
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Medical Foundation
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Forente stater, 53713
- Southern Wisconsin Radiotherapy Center
-
Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Clinic
-
Menomonee Falls, Wisconsin, Forente stater, 53051
- Community Memorial Hospital
-
Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Forente stater, 53211
- Columbia Hospital
-
Milwaukee, Wisconsin, Forente stater, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, Forente stater, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
-
Racine, Wisconsin, Forente stater, 53405
- All Saints Cancer Center
-
Waukesha, Wisconsin, Forente stater, 53188
- Waukesha Memorial Hospital
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Corey J. Langer, MD, Fox Chase Cancer Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2000
Primær fullføring (Faktiske)
1. november 2004
Studiet fullført (Faktiske)
1. november 2013
Datoer for studieregistrering
Først innsendt
6. april 2000
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. november 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- tilbakevendende metastatisk plateepitelkreft med okkult primær
- metastatisk plateepitelkreft med okkult primært plateepitelkarsinom
- stadium III plateepitelkarsinom i leppe og munnhule
- tilbakevendende plateepitelkarsinom i leppe og munnhule
- stadium III plateepitelkarsinom i orofarynx
- tilbakevendende plateepitelkarsinom i orofarynx
- stadium III plateepitelkarsinom i hypopharynx
- tilbakevendende plateepitelkarsinom i hypopharynx
- stadium III plateepitelkarsinom i strupehodet
- tilbakevendende plateepitelkarsinom i strupehodet
- stadium III plateepitelkarsinom i paranasal sinus og nesehulen
- tilbakevendende plateepitelkarsinom i paranasal sinus og nesehulen
- stadium I plateepitelkarsinom i leppe og munnhule
- stadium II plateepitelkarsinom i leppe og munnhule
- stadium I plateepitelkarsinom i paranasal sinus og nesehulen
- stadium II plateepitelkarsinom i paranasal sinus og nesehulen
- stadium I plateepitelkarsinom i hypopharynx
- stadium I plateepitelkarsinom i strupehodet
- stadium I plateepitelkarsinom i orofarynx
- stadium II plateepitelkarsinom i hypopharynx
- stadium II plateepitelkarsinom i strupehodet
- stadium II plateepitelkarsinom i orofarynx
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RTOG-9911
- CDR0000067705
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