Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage I salivary gland cancer, stage II salivary gland cancer, stage III salivary gland cancer, high-grade salivary gland mucoepidermoid carcinoma, salivary gland adenocarcinoma, stage IVA salivary gland cancer, stage IVB salivary gland cancer, stage IVC salivary gland cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes: Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma High-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma Surgical resection with curative intent within 8 weeks prior to registration All patients must have a Medical Oncology evaluation within 4 weeks prior to registration Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin; patients must be free of distant metastases based upon the following minimum diagnostic workup: History/physical examination within 8 weeks prior to registration Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required (PET/CT is acceptable) No patients with residual macroscopic disease after surgery No prior systemic chemotherapy or radiation therapy for salivary gland malignancy PATIENT CHARACTERISTICS: Zubrod performance status 0-1 Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3 Platelets ≥ 100,000 cells/mm^3 Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable) Serum creatinine < 2.0 mg/dL Total bilirubin < 2 x the institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment Not pregnant or nursing Patients must be deemed able to comply with the treatment plan and follow-up schedule Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) No severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (coagulation parameters are not required for entry into this protocol) Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol) Protocol-specific requirements may also exclude immunocompromised patients Pre-existing ≥ grade 2 neuropathy No significant pre-existing hearing loss, as defined by the patient or treating physician PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable) No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields No prior organ transplant No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy No concurrent erythropoiesis-stimulating agents
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- The Kirklin Clinic at Acton Road
- Arizona Breast Cancer Specialists-Gilbert
- Arizona Center for Cancer Care-Peoria
- Cancer Center at Saint Joseph's
- Arizona Breast Cancer Specialists-Phoenix
- Arizona Oncology-Deer Valley Center
- Arizona Breast Cancer Specialists
- Arizona Breast Cancer Specialists-Scottsdale
- Arizona Oncology Services Foundation
- Arizona Center for Cancer Care-Surprise
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- AIS Cancer Center at San Joaquin Community Hospital
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Mercy San Juan Medical Center
- City of Hope Comprehensive Cancer Center
- UC San Diego Moores Cancer Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Hoag Memorial Hospital
- Saint Joseph Hospital - Orange
- Stanford Cancer Institute Palo Alto
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- UCSF Medical Center-Mount Zion
- UCSF Medical Center-Mission Bay
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Rocky Mountain Cancer Centers-Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Swedish Medical Center
- Rocky Mountain Cancer Centers-Littleton
- Longmont United Hospital
- McKee Medical Center
- North Suburban Medical Center
- Rocky Mountain Cancer Centers-Thornton
- William Backus Hospital
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- University of Florida Health Science Center - Gainesville
- Baptist MD Anderson Cancer Center
- University of Florida Health Science Center - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Miami Cancer Institute
- Orlando Health Cancer Institute
- Moffitt Cancer Center
- Emory Proton Therapy Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Memorial Health University Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Clinic Cancer Services - Post Falls
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Loyola University Medical Center
- Saint John's Hospital
- IU Health North Hospital
- Goshen Center for Cancer Care
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- Memorial Hospital of South Bend
- McFarland Clinic PC - Ames
- Iowa Methodist Medical Center
- Mercy Medical Center - Des Moines
- University of Iowa/Holden Comprehensive Cancer Center
- Siouxland Regional Cancer Center
- University of Kansas Cancer Center
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- Mary Bird Perkins Cancer Center
- University Medical Center New Orleans
- Touro Infirmary
- Ochsner Medical Center Jefferson
- Greater Baltimore Medical Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Boston Medical Center
- Bixby Medical Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Henry Ford Cancer Institute-Downriver
- Henry Ford Macomb Hospital-Clinton Township
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Weisberg Cancer Treatment Center
- Genesys Hurley Cancer Institute
- West Michigan Cancer Center
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Ascension Saint Mary's Hospital
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Mayo Clinic in Rochester
- University of Mississippi Medical Center
- University of Missouri - Ellis Fischel
- Siteman Cancer Center at West County Hospital
- Freeman Health System
- Delbert Day Cancer Institute at PCRMC
- SSM Health Saint Louis University Hospital
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Siteman Cancer Center at Saint Peters Hospital
- Mercy Hospital Springfield
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Kalispell Regional Medical Center
- Nebraska Methodist Hospital
- Alegent Health Bergan Mercy Medical Center
- Comprehensive Cancer Centers of Nevada - Henderson
- Radiation Oncology Centers of Nevada Central
- Comprehensive Cancer Centers of Nevada - Northwest
- Comprehensive Cancer Centers of Nevada-Summerlin
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada - Central Valley
- Dartmouth Hitchcock Medical Center
- Memorial Sloan Kettering Basking Ridge
- Memorial Sloan Kettering Monmouth
- Memorial Sloan Kettering Bergen
- Virtua Memorial
- Rutgers New Jersey Medical School
- Sparta Cancer Treatment Center
- Virtua Voorhees
- University of New Mexico Cancer Center
- Northwell Health Imbert Cancer Center
- Maimonides Medical Center
- Memorial Sloan Kettering Commack
- Memorial Sloan Kettering Westchester
- Northwell Health/Center for Advanced Medicine
- Long Island Jewish Medical Center
- Mount Sinai Union Square
- Mount Sinai Chelsea
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Lenox Hill Hospital
- Mount Sinai Hospital
- Memorial Sloan Kettering Cancer Center
- Highland Hospital
- University of Rochester
- Memorial Sloan Kettering Sleepy Hollow
- State University of New York Upstate Medical University
- Memorial Sloan Kettering Nassau
- UNC Lineberger Comprehensive Cancer Center
- Duke University Medical Center
- Summa Health System - Akron Campus
- Summa Health System - Barberton Campus
- University of Cincinnati Cancer Center-UC Medical Center
- Case Western Reserve University
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mercy Cancer Center-Elyria
- Summa Health Medina Medical Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- University Hospitals Parma Medical Center
- UH Seidman Cancer Center at Salem Regional Medical Center
- UH Seidman Cancer Center at Firelands Regional Medical Center
- ProMedica Flower Hospital
- University of Toledo
- Mercy Health - Saint Anne Hospital
- University of Cincinnati Cancer Center-West Chester
- Cancer Treatment Center
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Clackamas Radiation Oncology Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Oregon Health and Science University
- Lehigh Valley Hospital-Cedar Crest
- Bryn Mawr Hospital
- Geisinger Medical Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- UPMC Jameson
- Paoli Memorial Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- UPMC-Saint Margaret
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Rapid City Regional Hospital
- University of Tennessee - Knoxville
- Vanderbilt University/Ingram Cancer Center
- MD Anderson in The Woodlands
- UT Southwestern/Simmons Cancer Center-Dallas
- M D Anderson Cancer Center
- MD Anderson West Houston
- MD Anderson League City
- MD Anderson in Sugar Land
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Utah Cancer Specialists-Salt Lake City
- Norris Cotton Cancer Center-North
- Inova Schar Cancer Institute
- Inova Fairfax Hospital
- Sentara Cancer Institute at Sentara CarePlex Hospital
- Sentara Norfolk General Hospital
- Sentara Virginia Beach General Hospital
- Saint Francis Hospital
- Seattle Cancer Care Alliance at Northwest Hospital
- University of Washington Medical Center - Montlake
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- West Virginia University Healthcare
- Wheeling Hospital/Schiffler Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- University of Wisconsin Hospital and Clinics
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Vince Lombardi Cancer Clinic-Sheboygan
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Aspirus Cancer Care - Wisconsin Rapids
- Cross Cancer Institute
- London Regional Cancer Program
- Health Sciences North
- University Health Network-Princess Margaret Hospital
- CHUM - Hopital Notre-Dame
- McGill University Department of Oncology
- CHUM - Centre Hospitalier de l'Universite de Montreal
- The Research Institute of the McGill University Health Centre (MUHC)
- King Faisal Specialist Hospital and Research Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
Patients undergo 3D-CRT or IMRT as in arm I.