- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00008398
Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain (Mucositis) Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer. It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the efficacy of sargramostim (GM-CSF) in terms of reducing the severity and expected duration of radiotherapy-induced oral mucositis in patients with head and neck cancer receiving radiotherapy.
- Determine the correlation between reduced mucosal injury and quality of life improvement in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to concurrent cisplatin chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy once daily five days a week for 6-7 weeks. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) three times a week (except on days if receiving concurrent cisplatin) beginning 1 week prior to radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total of approximately 9 weeks.
- Arm II: Patients receive radiotherapy as in arm I. Patients also receive placebo SC on the same schedule as GM-CSF in arm I.
Quality of life is assessed at baseline, and then at 3, 6, and 12 months.
Patients are followed at 3, 6 and 11 months.
PROJECTED ACCRUAL: A total of 126 patients (63 per arm) will be accrued within 1.2-1.4 years.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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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-4M1
- 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, United States, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Huntsville, Alabama, United States, 35801
- Comprehensive Cancer Institute of Huntsville
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Huntsville, Alabama, United States, 35801-4470
- Huntsville Hospital System
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Mobile, Alabama, United States, 36688
- MBCCOP - Gulf Coast
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Montgomery, Alabama, United States, 36106-2801
- Alabama Oncology, LLC
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Tuscaloosa, Alabama, United States, 35401
- Radiation Oncology Associates of West Alabama
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Arizona
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Phoenix, Arizona, United States, 85013
- Foundation for Cancer Research and Education
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California
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Concord, California, United States, 94524-4110
- Mount Diablo Medical Center
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Duarte, California, United States, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Fresno, California, United States, 93720
- California Cancer Center
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Fresno, California, United States, 93720
- Saint Agnes Cancer Center
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Greenbrae, California, United States, 94904
- Sutter Health West Cancer Research Group
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Pasadena, California, United States, 91105
- Huntington Cancer Center
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Pomona, California, United States, 91767
- Cancer Care Center
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Sacramento, California, United States, 95816
- Radiation Oncology Center - Sacramento
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San Diego, California, United States, 92101-1492
- Radiation Medical Group, Inc.
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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San Jose, California, United States, 95128
- O'Connor Hospital
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Stockton, California, United States, 95204
- St. Joseph's Regional Health System
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Colorado Springs, Colorado, United States, 80909
- Memorial Hospital Cancer Center
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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Grand Junction, Colorado, United States, 81502
- Saint Mary's Hospital and Medical Center
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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Florida
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Gainesville, Florida, United States, 32610-0296
- University of Florida Health Science Center
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Jacksonville, Florida, United States, 32207
- Edna Williams Cancer Treatment Center
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Melbourne, Florida, United States, 32901
- Health First Holmes Regional Medical Center
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Miami, Florida, United States, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, United States, 33176-2197
- Baptist Hospital of Miami
-
Miami, Florida, United States, 33125
- Veterans Affairs Medical Center - Miami
-
Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, United States, 32806
- MD Anderson Cancer Center Orlando
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Panama City, Florida, United States, 32405-4587
- Gulf Coast Cancer Treatment Center
-
Panama City, Florida, United States, 32401
- Bay Medical Center
-
Sarasota, Florida, United States, 34233
- Sarasota Radiation and Medical Oncology Center
-
Tallahassee, Florida, United States, 32308
- Tallahassee Memorial HealthCare
-
Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
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Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
-
Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
-
Columbus, Georgia, United States, 31902
- Medical Center/John B. Amos Community Cancer Center
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Rome, Georgia, United States, 30165
- Regional Radiation Oncology Center at Rome
-
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Hawaii
-
Honolulu, Hawaii, United States, 96813
- MBCCOP - Hawaii
-
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Illinois
-
Arlington Heights, Illinois, United States, 60005
- Northwest Community Hospital
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Harvey, Illinois, United States, 60426
- Ingalls Memorial Hospital
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, United States, 60068
- Lutheran General Cancer Care Center
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Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
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Indiana
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Anderson, Indiana, United States, 46016
- St. John's Medical Center
-
Bloomington, Indiana, United States, 47402
- Bloomington Hospital
-
Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Indianapolis, Indiana, United States, 46206-1367
- Clarian Health Partners Inc.
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Indianapolis, Indiana, United States, 46219
- Regional Cancer Center
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Lafayette, Indiana, United States, 47904
- Oncology Institute of Greater Lafayette
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Muncie, Indiana, United States, 47303-3499
- Ball Memorial Hospital
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
-
Dubuque, Iowa, United States, 52001
- Wendt Regional Cancer Center of Finley Hospital
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Kentucky
-
Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, United States, 40503
- Central Baptist Hospital
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Lexington, Kentucky, United States, 40504
- Lexington Clinic Cancer Center
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Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center
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Louisville, Kentucky, United States, 40215
- Louisville Radiation Oncology
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Madisonville, Kentucky, United States, 42431
- Merle M. Mahr Cancer Center
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center
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Maryland
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Annapolis, Maryland, United States, 21401
- Anne Arundel Oncology Center
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, United States, 21225
- Sinai Hospital of Baltimore
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Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center and Cancer Center
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Baltimore, Maryland, United States, 21225
- Harbor Hospital Center
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Salisbury, Maryland, United States, 21801
- Peninsula Regional Medical Center
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Massachusetts
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Hyannis, Massachusetts, United States, 02601
- Cape Cod Hospital
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Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Flint, Michigan, United States, 48432
- McLaren Regional Cancer Center
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Marquette, Michigan, United States, 49855
- Marquette General Hospital
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Midland, Michigan, United States, 48670
- MidMichigan Medical Center - Midland
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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Troy, Michigan, United States, 48098
- William Beaumont Hospital - Troy
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
-
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, United States, 63108
- Mallinckrodt Institute of Radiology
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, United States, 65807
- Cancer Research for the Ozarks
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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Nebraska
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Omaha, Nebraska, United States, 68114
- Methodist Cancer Center - Omaha
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, United States, 68198-7460
- Nebraska Health System
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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Manchester, New Hampshire, United States, 03103
- Elliot Regional Cancer Center
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New Jersey
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East Orange, New Jersey, United States, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Edison, New Jersey, United States, 08818
- John F. Kennedy Medical Center
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Elizabeth, New Jersey, United States, 07201
- Trinitas Hospital - Jersey Street Campus
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Long Branch, New Jersey, United States, 07740-6395
- Monmouth Medical Center
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Millville, New Jersey, United States, 08332
- South Jersey Regional Cancer Center
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Mount Holly, New Jersey, United States, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
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Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
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Pomona, New Jersey, United States, 08240
- Atlantic City Medical Center
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Ridgewood, New Jersey, United States, 07450
- Valley Hospital
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Toms River, New Jersey, United States, 08755
- Community Medical Center
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Trenton, New Jersey, United States, 08629
- St. Francis Medical Center
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Warren, New Jersey, United States, 07059
- Associated Radiologists, P.A.
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Radiation Oncology Associates of Albuquerque
-
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New York
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Albany, New York, United States, 12208
- Cancer Center of Albany Medical Center
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Binghamton, New York, United States, 13905
- Lourdes Regional Cancer Center
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Brooklyn, New York, United States, 11203
- State University of New York Health Science Center at Brooklyn
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Brooklyn, New York, United States, 11215-3609
- New York Methodist Hospital
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Clifton Springs, New York, United States, 14432
- Finger Lakes Radiation Oncology Center
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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Plattsburgh, New York, United States, 12901
- Champlain Valley Physicians Hospital Medical Center
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Poughkeepsie, New York, United States, 12601
- Vassar Brothers Hospital
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Rochester, New York, United States, 14642
- University of Rochester Cancer Center
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Setauket, New York, United States, 11733
- North Shore Radiation Oncology
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Yonkers, New York, United States, 10701
- Riverhill Radiation Oncology
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, United States, 28025
- Northeast Medical Center
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Greenville, North Carolina, United States, 27858-4354
- East Carolina University School of Medicine
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Raleigh, North Carolina, United States, 27607
- Rex Healthcare
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Minot, North Dakota, United States, 58701
- Trinity Cancer Care Center
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Ohio
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Akron, Ohio, United States, 44302
- Akron General Medical Center
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Akron, Ohio, United States, 44309
- Akron City Hospital
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Cincinnati, Ohio, United States, 45219
- Christ Hospital
-
Cincinnati, Ohio, United States, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Cleveland, Ohio, United States, 44195-5044
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Kettering, Ohio, United States, 45429
- CCOP - Dayton
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
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Oklahoma
-
Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, United States, 73101
- St. Anthony Hospital
-
Tulsa, Oklahoma, United States, 74104
- St. John Health System
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Oregon
-
Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
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Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- LeHigh Valley Hospital
-
Bethlehem, Pennsylvania, United States, 18015
- St. Luke's Hospital Regional Cancer Center
-
Danville, Pennsylvania, United States, 17822-2001
- Geisinger Medical Center
-
Darby, Pennsylvania, United States, 19023
- Mercy Fitzgerald Hospital
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Drexel Hill, Pennsylvania, United States, 19026
- Delaware County Memorial Hospital
-
East Stroudsburg, Pennsylvania, United States, 18301
- Pocono Cancer Center
-
Hershey, Pennsylvania, United States, 17033-0850
- Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, United States, 19104
- Veterans Affairs Medical Center - Philadelphia
-
Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Cancer Center
-
Philadelphia, Pennsylvania, United States, 19104-4283
- University of Pennsylvania Cancer Center
-
Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Hospital
-
Pittsburgh, Pennsylvania, United States, 15213-3489
- University of Pittsburgh Cancer Institute
-
Pittsburgh, Pennsylvania, United States, 15219
- Mercy Hospital of Pittsburgh
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Reading, Pennsylvania, United States, 19612-6052
- Reading Hospital and Medical Center
-
Scranton, Pennsylvania, United States, 18501
- Mercy Hospital Cancer Center - Scranton
-
Wilkes-Barre, Pennsylvania, United States, 18764
- Wilkes Barre General Hospital
-
York, Pennsylvania, United States, 17315
- York Hospital
-
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Rhode Island
-
Providence, Rhode Island, United States, 02908-4735
- Roger Williams Medical Center/BUSM
-
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South Carolina
-
Greenville, South Carolina, United States, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
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South Dakota
-
Rapid City, South Dakota, United States, 57709
- Rapid City Regional Hospital
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Tennessee
-
Jackson, Tennessee, United States, 38301
- Jackson-Madison County General Hospital
-
Memphis, Tennessee, United States, 38103
- University of Tennessee, Memphis Cancer Center
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
-
Amarillo, Texas, United States, 79106
- Harrington Cancer Center
-
Galveston, Texas, United States, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, United States, 78236-5300
- Wilford Hall - 59th Medical Wing
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Lubbock, Texas, United States, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
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Utah
-
Saint George, Utah, United States, 84770
- Dixie Regional Medical Center
-
Salt Lake City, Utah, United States, 84132
- University of Utah Health Sciences Center
-
Salt Lake City, Utah, United States, 84143
- Latter Day Saints Hospital
-
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Vermont
-
Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
-
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Virginia
-
Charlottesville, Virginia, United States, 22908
- Cancer Center at the University of Virginia
-
Harrisonburg, Virginia, United States, 22801
- RMH Regional Cancer Center
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Portsmouth, Virginia, United States, 23708-2197
- Naval Medical Center, Portsmouth
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Richmond, Virginia, United States, 23298-0037
- Massey Cancer Center
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Richmond, Virginia, United States, 23226
- Bon-Secours - St. Mary's Hospital
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Washington
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Seattle, Washington, United States, 98111
- Virginia Mason Medical Center
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Spokane, Washington, United States, 99210-0248
- Deaconess Medical Center
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Yakima, Washington, United States, 98902
- Yakima Valley Memorial Hospital
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West Virginia
-
Wheeling, West Virginia, United States, 26003
- Schiffler Cancer Center
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Wisconsin
-
Green Bay, Wisconsin, United States, 54307-3508
- St. Vincent Hospital
-
Green Bay, Wisconsin, United States, 54301
- CCOP - Green Bay
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Foundation
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, United States, 53713
- Southern Wisconsin Radiotherapy Center
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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Menomonee Falls, Wisconsin, United States, 53051
- Community Memorial Hospital
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- Columbia Hospital
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Milwaukee, Wisconsin, United States, 53215
- St. Luke's Medical Center
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Racine, Wisconsin, United States, 53405
- All Saints Cancer Center
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Waukesha, Wisconsin, United States, 53188
- Waukesha Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed head and neck carcinoma with planned external beam radiotherapy to include 50% of oropharynx, oral cavity, or both]
- Planned external beam radiotherapy of 60-70 Gy total dose to the primary tumor or standard ports for an unknown primary tumor
- Neck metastases from an unknown primary allowed if radiotherapy planned to at least 50% of the salivary gland at a dose of at least 50 Gy
- No T1-T2 glottic tumors
- No residual oral/oropharyngeal injury from prior chemotherapy
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No allergy or idiosyncratic response to sargramostim (GM-CSF)
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No concurrent chemotherapy other than cisplatin
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to the head and neck
Surgery:
- Not specified
Other:
- No concurrent enrollment on other RTOG head and neck studies
- No concurrent oral care medications (e.g., amifostine, chlorhexidrine gluconate, sucralfate, or benzydamine HCl) during study radiotherapy
- No concurrent selective oral cavity decontamination (e.g., IB-367) during study radiotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Francis G. LeVeque, DDS, Barbara Ann Karmanos Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- radiation toxicity
- oral complications
- stage I nasopharyngeal cancer
- stage II nasopharyngeal cancer
- recurrent hypopharyngeal cancer
- stage III hypopharyngeal cancer
- stage IV hypopharyngeal cancer
- recurrent lip and oral cavity cancer
- stage III lip and oral cavity cancer
- stage IV lip and oral cavity cancer
- recurrent nasopharyngeal cancer
- stage III nasopharyngeal cancer
- stage IV nasopharyngeal cancer
- recurrent oropharyngeal cancer
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- recurrent paranasal sinus and nasal cavity cancer
- stage III paranasal sinus and nasal cavity cancer
- stage IV paranasal sinus and nasal cavity cancer
- stage I hypopharyngeal cancer
- stage II hypopharyngeal cancer
- stage I lip and oral cavity cancer
- stage II lip and oral cavity cancer
- stage I oropharyngeal cancer
- stage II oropharyngeal cancer
- stage I paranasal sinus and nasal cavity cancer
- stage II paranasal sinus and nasal cavity cancer
- stage 0 oropharyngeal cancer
- stage 0 lip and oral cavity cancer
- stage 0 laryngeal cancer
- stage 0 hypopharyngeal cancer
- stage 0 paranasal sinus and nasal cavity cancer
- stage 0 nasopharyngeal cancer
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTOG-9901
- CDR0000068406
- NCI-P00-0177
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Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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Radboud University Medical CenterUnknown
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WepromNeptuneActive, not recruitingMetastatic Colorectal Cancer | Metastatic Head and Neck CancerFrance
Clinical Trials on radiation therapy
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NRG OncologyNational Cancer Institute (NCI)RecruitingUnrectable or Locally Recurrent Hepatocellular CarcinomaUnited States
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University of California, San FranciscoVarian Medical SystemsRecruitingStage IV Anal Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Postneoadjuvant Therapy Stage... and other conditionsUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumor | Central Nervous System TumorUnited States, Canada, Australia, Puerto Rico, Switzerland, New Zealand
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Medical College of WisconsinRecruitingHead and Neck CancerUnited States
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Medical College of WisconsinRecruitingResectable Head and Neck Squamous Cell CarcinomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)Completed
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Changhai HospitalRecruitingLocalized Prostate CancerChina
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NYU Langone HealthCompletedBreast CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
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Medical College of WisconsinActive, not recruitingHigh-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)Prostate CancerUnited States