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Radiation Therapy with or without Chemotherapy in Treating Patients with High-Risk Malignant Salivary Gland Tumors That Have Been Removed by Surgery

Trial Status: Active

This randomized phase II / III trial studies radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery. Radiation therapy uses high-energy x-rays or protons to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors.

Inclusion Criteria

  • 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 adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary duct carcinoma * High-grade acinic cell carcinoma or high-grade (> 30% solid component) adenoid cystic carcinoma * Patients with diagnoses such as "undifferentiated or poorly differentiated carcinoma", "carcinoma-ex pleomorphic adenoma", "carcinoma not otherwise specified (NOS)" and others should be considered for this trial
  • Surgical resection with curative intent within 8 weeks prior to registration
  • Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (=< 1 mm) or microscopically positive surgical margin (American Joint Committee on Cancer [AJCC], 7th edition); 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 computed tomography (CT) imaging of the chest is required; positron emission tomography (PET)/CT is acceptable
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 (within 8 weeks prior to registration)
  • Platelets >= 100,000 cells/mm^3 (within 8 weeks prior to registration)
  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) (within 8 weeks prior to registration)
  • Serum creatinine < 2.0 mg/dl (within 8 weeks prior to registration)
  • Total bilirubin < 2 x the institutional upper limit of normal (ULN) (within 8 weeks prior to registration)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN (within 8 weeks prior to registration)
  • 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
  • All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
  • 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

Exclusion Criteria

  • Patients with residual macroscopic disease after surgery
  • 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)
  • Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • 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; note, however, coagulation parameters are not required for entry into this protocol * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol * Pre-existing >= grade 2 neuropathy * Prior organ transplant
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Significant pre-existing hearing loss, as defined by the patient or treating physician

Alabama

Birmingham
The Kirklin Clinic at Acton Road
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

Arizona

Gilbert
Arizona Breast Cancer Specialists-Gilbert
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 480-922-4600
Peoria
Arizona Center for Cancer Care-Peoria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 623-773-2873
Phoenix
Arizona Breast Cancer Specialists-Phoenix
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 480-922-4600
Arizona Oncology Associates-Deer Valley Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 623-587-4868
Cancer Center at Saint Joseph's
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 602-406-8222
Scottsdale
Arizona Breast Cancer Specialists
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 480-922-4600
Arizona Breast Cancer Specialists-Scottsdale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 480-922-4600
Arizona Oncology Services Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-360-6371
Surprise
Arizona Center for Cancer Care-Surprise
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-339-5294
Tucson
Banner University Medical Center - Tucson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
University of Arizona Cancer Center-North Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-327-2873
University of Arizona Cancer Center-Orange Grove Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 520-694-8900

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 661-323-4673
Burlingame
Mills-Peninsula Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Carmichael
Mercy San Juan Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 916-556-3301
Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-826-4673
La Jolla
UC San Diego Moores Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 858-822-5354
Los Angeles
Los Angeles County-USC Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Marysville
Fremont - Rideout Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 530-749-4400
Modesto
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Newport Beach
Hoag Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 949-722-6237
Orange
Saint Joseph Hospital - Orange
Status: ACTIVE
Contact: Site Public Contact
Phone: 714-734-6220
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Site Public Contact
Phone: 650-498-7061
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
Sacramento
Sutter Medical Center Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
UCSF Medical Center-Mission Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-3222
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-3222
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 415-209-2686

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 720-848-0650
Boulder
Boulder Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Denver
Porter Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Englewood
Swedish Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Littleton
Rocky Mountain Cancer Centers-Littleton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Longmont
Longmont United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Loveland
McKee Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Thornton
North Suburban Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-451-7800
Rocky Mountain Cancer Centers-Thornton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518

Connecticut

Norwich
William Backus Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-339-5294

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 302-645-3100

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-243-2647
Gainesville
University of Florida Health Science Center - Gainesville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 352-273-8010
Jacksonville
Baptist MD Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 904-202-7468
University of Florida Health Science Center - Jacksonville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-254-7581
Miami
Miami Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 786-596-2000
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
UF Cancer Center at Orlando Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 321-841-7246
Tampa
Moffitt Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-679-0775

Georgia

Atlanta
Emory Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-251-2854
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Savannah
Memorial Health University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-350-7887

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Post Falls
Kootenai Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-864-5204
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Springfield
Saint John's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-525-5666

Indiana

Carmel
IU Health North Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Goshen
Goshen Center for Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-364-2973
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Sidney and Lois Eskenazi Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
South Bend
Memorial Hospital of South Bend
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-284-7370

Iowa

Ames
McFarland Clinic PC - Ames
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-239-4734
Des Moines
Iowa Methodist Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-6727
Mercy Medical Center - Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-237-1225
Sioux City
Siouxland Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 712-252-9326

Kansas

Kansas City
University of Kansas Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-562-3429

Louisiana

Baton Rouge
Mary Bird Perkins Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-215-1353
New Orleans
Ochsner Medical Center Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-703-8712
Touro Infirmary
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-210-3539
University Medical Center New Orleans
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 504-210-3539

Maryland

Baltimore
Greater Baltimore Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 443-849-3706
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-955-8804

Massachusetts

Boston
Boston Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 617-638-8265

Michigan

Adrian
Bixby Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute-Downriver
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Farmington Hills
Weisberg Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-576-9790
Flint
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Kalamazoo
West Michigan Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Livonia
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Pontiac
Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Port Huron
Lake Huron Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Warren
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Columbia
University of Missouri - Ellis Fischel
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-882-7440
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Joplin
Freeman Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-347-4030
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Saint Louis
Saint Louis University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-977-4440
Siteman Cancer Center-South County
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606

Montana

Billings
Billings Clinic Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Omaha
Alegent Health Bergan Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas
Comprehensive Cancer Centers of Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-639-6918

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Mount Holly
Virtua Memorial
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 609-914-6762
Newark
Rutgers New Jersey Medical School
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 732-235-8675
Sparta
Sparta Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 973-729-7001
Voorhees
Virtua Voorhees
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 856-247-7395

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-925-0366

New York

Bay Shore
Northwell Health Imbert Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 516-734-8896
Brooklyn
Maimonides Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-765-2500
Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Lake Success
Northwell Health / Center for Advanced Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 516-734-8896
New Hyde Park
Long Island Jewish Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 516-734-8896
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-263-4434
Lenox Hill Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 516-734-8896
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Mount Sinai Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Mount Sinai Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Mount Sinai Union Square
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Rochester
Highland Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Sleepy Hollow
Memorial Sloan Kettering Sleepy Hollow
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7202
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-275-3853

Ohio

Akron
Summa Health System - Akron Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 330-375-4221
Barberton
Summa Health System - Barberton Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 330-375-4221
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-558-4553
Cleveland
Case Western Reserve University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-293-5066
Elyria
Mercy Cancer Center-Elyria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Medina
Summa Health Medina Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 330-375-4221
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Parma
University Hospitals Parma Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Salem
UH Seidman Cancer Center at Salem Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Sylvania
ProMedica Flower Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
Mercy Saint Anne Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-407-1160
University of Toledo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-383-6583
West Chester
University Pointe
Status: ACTIVE
Contact: Site Public Contact
Wooster
Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 330-375-4221

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Oregon Health and Science University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-494-1080
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-476-2649
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-838-1900
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-724-6765
Hershey
Penn State Milton S Hershey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-531-3779
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-242-7703
Moon Township
UPMC-Coraopolis / Heritage Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-604-2020
New Castle
UPMC Jameson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 724-656-5870
Paoli
Paoli Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-476-2649
Philadelphia
Fox Chase Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-728-4790
Temple University Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-728-2983
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-955-6084
Pittsburgh
UPMC Jefferson Regional Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-469-5500
UPMC-Passavant Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-502-3920
UPMC-Saint Margaret
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-784-4900
UPMC-Shadyside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-621-2334
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Wynnewood
Lankenau Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 484-476-2649

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Greenville
Prisma Health Cancer Institute - Eastside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Prisma Health Cancer Institute - Greer
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066

South Dakota

Rapid City
Rapid City Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-716-3982

Tennessee

Knoxville
University of Tennessee - Knoxville
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-544-9773
Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Conroe
MD Anderson in The Woodlands
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-632-6789
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
MD Anderson West Houston
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
League City
MD Anderson League City
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
Sugar Land
MD Anderson in Sugar Land
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-855-4100
Cedar City
Sandra L Maxwell Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-868-5680
Logan
Logan Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-716-6400
Murray
Intermountain Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-507-3950
Provo
Utah Valley Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-357-7965
Saint George
Dixie Medical Center Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-688-4167
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-933-6070

Vermont

Saint Johnsbury
Norris Cotton Cancer Center-North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 802-473-4100

Virginia

Fairfax
Inova Schar Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 703-720-5210
Falls Church
Inova Fairfax Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 703-208-6650
Hampton
Sentara Cancer Institute at Sentara CarePlex Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 757-388-2840
Norfolk
Sentara Norfolk General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 757-388-2406
Virginia Beach
Sentara Virginia Beach General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 757-388-2840

Washington

Federal Way
Saint Francis Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Seattle
Seattle Cancer Care Alliance at Northwest Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-606-5800
University of Washington Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824
Vancouver
Compass Oncology Vancouver
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-449-6521
PeaceHealth Southwest Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-3940

West Virginia

Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Germantown
Aurora Health Care Germantown Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Grafton
Aurora Cancer Care-Grafton
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay Oncology at Saint Vincent Hospital
Status: ACTIVE
Contact: Eva N. Christensen
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center Green Bay
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
Kenosha
Aurora Cancer Care-Kenosha South
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-622-8922
Marinette
Aurora Bay Area Medical Group-Marinette
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Bay Area Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Milwaukee
Aurora Cancer Care-Milwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Racine
Aurora Cancer Care-Racine
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
Summit
Aurora Medical Center in Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
West Allis
Aurora West Allis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Wisconsin Rapids
Aspirus UW Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 715-422-7718

Alberta

Edmonton
Cross Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 780-432-8500

Ontario

London
London Regional Cancer Program
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 519-685-8600
Sudbury
Health Sciences North
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 706-522-6237ext2401
Toronto
University Health Network-Princess Margaret Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 416-946-4501

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 514-890-8000ext12725
CHUM - Hopital Notre-Dame
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
McGill University Department of Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: George Shenouda
Phone: 514-934-1934ext42953
The Research Institute of the McGill University Health Centre (MUHC)
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-934-1934ext48354

Saudi Arabia

Riyadh
King Faisal Specialist Hospital and Research Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 011-966-1-464-7272 ext 38005

PRIMARY OBJECTIVES:

I. Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors. (Phase II)

II. Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. (Phase II)

III. Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone. (Phase III)

SECONDARY OBJECTIVES:

I. Compare the acute toxicities of these 2 adjuvant treatments.

II. Compare late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.

III. Compare progression-free survival rates among patients receiving cisplatin and radiation to those receiving radiation alone in both the cohort of patients with pathologically high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma, salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk disease (all other eligible diagnoses).

IV. Investigate quality of life and patient-reported outcomes in patients enrolled in the study.

V. Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies.

VI. Establish an NRG Oncology baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.

OUTLINE: Patients are stratified according to histology (intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma vs high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma or salivary duct carcinoma vs high-grade acinic cell carcinoma or high-grade [> 30% solid component] adenoid cystic carcinoma), nodal status (N0 vs N1-3), and type of radiation (photon vs proton). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT), intensity-modulated radiation therapy (IMRT), or intensity modulated proton therapy (IMPT) 5 days a week for 6 or 6.5 weeks. Patients also receive cisplatin intravenously (IV) over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.

Arm II: Patients undergo 3D-CRT, IMRT, or IMPT as in Arm I.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, and 24 months, every 6 months for 2 years, and then annually thereafter.

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Cristina Paguia Rodriguez

  • Primary ID RTOG-1008
  • Secondary IDs NCI-2013-00370, CDR0000686072, NCI-2011-00795
  • Clinicaltrials.gov ID NCT01220583