Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Head and Neck Cancer, Oral Complications, Radiation Toxicity
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring stage I nasopharyngeal cancer, stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer, recurrent nasopharyngeal cancer, stage 0 paranasal sinus and nasal cavity cancer, stage 0 nasopharyngeal cancer, stage 0 oropharyngeal cancer, stage 0 laryngeal cancer, stage 0 hypopharyngeal cancer, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, stage 0 lip and oral cavity cancer, stage I lip and oral cavity cancer, stage II lip and oral cavity cancer, stage III lip and oral cavity cancer, stage IV lip and oral cavity cancer, recurrent lip and oral cavity cancer, stage I hypopharyngeal cancer, stage II hypopharyngeal cancer, stage III hypopharyngeal cancer, stage IV hypopharyngeal cancer, recurrent hypopharyngeal cancer, stage I paranasal sinus and nasal cavity cancer, stage II paranasal sinus and nasal cavity cancer, stage III paranasal sinus and nasal cavity cancer, stage IV paranasal sinus and nasal cavity cancer, recurrent paranasal sinus and nasal cavity cancer, stage I oropharyngeal cancer, stage II oropharyngeal cancer, stage III oropharyngeal cancer, stage IV oropharyngeal cancer, recurrent oropharyngeal cancer, oral complications, radiation toxicity
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Huntsville Hospital System
- Comprehensive Cancer Institute of Huntsville
- MBCCOP - Gulf Coast
- Alabama Oncology, LLC
- Radiation Oncology Associates of West Alabama
- Foundation for Cancer Research and Education
- Mount Diablo Medical Center
- Cancer Center and Beckman Research Institute, City of Hope
- California Cancer Center
- Saint Agnes Cancer Center
- Sutter Health West Cancer Research Group
- Loma Linda University Medical Center
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- CCOP - Bay Area Tumor Institute
- Huntington Cancer Center
- Cancer Care Center
- Radiation Oncology Center - Sacramento
- Radiation Medical Group, Inc.
- UCSF Cancer Center and Cancer Research Institute
- O'Connor Hospital
- CCOP - Santa Rosa Memorial Hospital
- St. Joseph's Regional Health System
- David Grant Medical Center
- Memorial Hospital Cancer Center
- University of Colorado Cancer Center
- Saint Mary's Hospital and Medical Center
- CCOP - Christiana Care Health Services
- University of Florida Health Science Center
- Edna Williams Cancer Treatment Center
- Health First Holmes Regional Medical Center
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Miami
- Sylvester Cancer Center, University of Miami
- Baptist Hospital of Miami
- MD Anderson Cancer Center Orlando
- Bay Medical Center
- Gulf Coast Cancer Treatment Center
- Sarasota Radiation and Medical Oncology Center
- Tallahassee Memorial Healthcare
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital - Atlanta
- CCOP - Atlanta Regional
- Medical Center/John B. Amos Community Cancer Center
- Regional Radiation Oncology Center at Rome
- MBCCOP - Hawaii
- Northwest Community Hospital
- Northwestern Memorial Hospital
- CCOP - Central Illinois
- Ingalls Memorial Hospital
- Loyola University Medical Center
- Lutheran General Cancer Care Center
- Methodist Medical Center of Illinois
- St. John's Medical Center
- Bloomington Hospital
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Clarian Health Partners Inc.
- Regional Cancer Center
- Oncology Institute of Greater Lafayette
- Ball Memorial Hospital
- CCOP - Northern Indiana CR Consortium
- Wendt Regional Cancer Center of Finley Hospital
- Central Baptist Hospital
- Lexington Clinic Cancer Center
- Albert B. Chandler Medical Center, University of Kentucky
- James Graham Brown Cancer Center
- Louisville Radiation Oncology
- Merle M. Mahr Cancer Center
- Mary Bird Perkins Cancer Center
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- CCOP - Ochsner
- Maine Medical Center
- Anne Arundel Oncology Center
- Greater Baltimore Medical Center and Cancer Center
- Harbor Hospital Center
- Sinai Hospital of Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Peninsula Regional Medical Center
- Cape Cod Hospital
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- McLaren Regional Cancer Center
- Hurley Medical Center
- CCOP - Kalamazoo
- Marquette General Hospital
- MidMichigan Medical Center - Midland
- William Beaumont Hospital
- William Beaumont Hospital - Troy
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Ellis Fischel Cancer Center - Columbia
- CCOP - Kansas City
- Mallinckrodt Institute of Radiology
- St. Louis University Health Sciences Center
- Cancer Research for the Ozarks
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- CCOP - Missouri Valley Cancer Consortium
- Methodist Cancer Center - Omaha
- Nebraska Health System
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Elliot Regional Cancer Center
- Veterans Affairs Medical Center - East Orange
- John F. Kennedy Medical Center
- Trinitas Hospital - Jersey Street Campus
- Monmouth Medical Center
- South Jersey Regional Cancer Center
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- Atlantic City Medical Center
- Valley Hospital
- Community Medical Center
- St. Francis Medical Center
- Associated Radiologists, P.A.
- Radiation Oncology Associates of Albuquerque
- Cancer Center of Albany Medical Center
- Lourdes Regional Cancer Center
- State University of New York Health Science Center at Brooklyn
- New York Methodist Hospital
- Finger Lakes Radiation Oncology Center
- CCOP - North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- Herbert Irving Comprehensive Cancer Center
- Champlain Valley Physicians Hospital Medical Center
- Vassar Brothers Hospital
- University of Rochester Cancer Center
- North Shore Radiation Oncology
- State University of New York - Upstate Medical University
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Riverhill Radiation Oncology
- Lineberger Comprehensive Cancer Center, UNC
- Northeast Medical Center
- East Carolina University School of Medicine
- Rex Healthcare
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Trinity Cancer Care Center
- Akron General Medical Center
- Akron City Hospital
- Christ Hospital
- Barrett Cancer Center, The University Hospital
- Ireland Cancer Center
- University Hospitals of Cleveland
- Cleveland Clinic Foundation
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- CCOP - Dayton
- CCOP - Toledo Community Hospital Oncology Program
- St. Anthony Hospital
- University of Oklahoma Health Sciences Center
- St. John Health System
- CCOP - Columbia River Program
- Lehigh Valley Hospital
- St. Luke's Hospital Regional Cancer Center
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Delaware County Memorial Hospital
- Pocono Cancer Center
- Milton S. Hershey Medical Center
- University of Pennsylvania Cancer Center
- Veterans Affairs Medical Center - Philadelphia
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Albert Einstein Cancer Center
- University of Pittsburgh Cancer Institute
- Mercy Hospital of Pittsburgh
- Western Pennsylvania Hospital
- Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Wilkes Barre General Hospital
- York Hospital
- Roger Williams Medical Center/BUSM
- CCOP - Greenville
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Jackson-Madison County General Hospital
- University of Tennessee, Memphis Cancer Center
- Vanderbilt-Ingram Cancer Center
- Harrington Cancer Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Wilford Hall - 59th Medical Wing
- Joe Arrington Cancer Research and Treatment Center
- Dixie Regional Medical Center
- University of Utah Health Sciences Center
- Latter Day Saints Hospital
- Vermont Cancer Center
- Cancer Center at the University of Virginia
- RMH Regional Cancer Center
- Naval Medical Center, Portsmouth
- Bon-Secours - St. Mary's Hospital
- Massey Cancer Center
- Virginia Mason Medical Center
- Deaconess Medical Center
- Yakima Valley Memorial Hospital
- Schiffler Cancer Center
- CCOP - Green Bay
- St. Vincent Hospital
- Gundersen Lutheran Medical Foundation
- Southern Wisconsin Radiotherapy Center
- University of Wisconsin Comprehensive Cancer Center
- Marshfield Clinic
- Community Memorial Hospital
- Columbia Hospital
- St. Luke's Medical Center
- Medical College of Wisconsin
- All Saints Cancer Center
- Waukesha Memorial Hospital
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Toronto Sunnybrook Regional Cancer Centre
- Princess Margaret Hospital
- CHUS-Hopital Fleurimont
- Centre Hospitalier de l'Universite de Montreal
- McGill University
- Centre Hospitalier Universitaire de Quebec
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre