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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Alabama

Birmingham
The Kirklin Clinic at Acton Road
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu

Arizona

Gilbert
Arizona Breast Cancer Specialists-Gilbert
Status: Active
Contact: Site Public Contact
Phone: 480-922-4600
Peoria
Arizona Center for Cancer Care-Peoria
Status: Active
Contact: Site Public Contact
Phone: 623-773-2873
Phoenix
Arizona Breast Cancer Specialists-Phoenix
Status: Active
Contact: Site Public Contact
Phone: 480-922-4600
Email: renee.schein@arizonaccc.com
Arizona Oncology Associates-Deer Valley Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 623-587-4868
Scottsdale
Arizona Breast Cancer Specialists
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 480-922-4600
Arizona Breast Cancer Specialists-Scottsdale
Status: Active
Contact: Site Public Contact
Phone: 480-922-4600
Surprise
Arizona Center for Cancer Care-Surprise
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Tucson
Banner University Medical Center - Tucson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: aselegue@email.arizona.edu
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

Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 661-323-4673
Carmichael
Mercy San Juan Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-556-3301
Email: OncologyResearch@DignityHealth.org
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
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
Newport Beach
Hoag Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 949-722-6237
Email: HoagCancerCenter@hoag.org
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Site Public Contact
Phone: 650-498-7061
Email: ccto-office@stanford.edu
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
UCSF Medical Center-Mount Zion
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-827-3222

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
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
Email: jbloomfield@co-cancerresearch.org
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Denver
Porter Adventist Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Englewood
Swedish Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Littleton
Rocky Mountain Cancer Centers-Littleton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Longmont
Longmont United Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Loveland
McKee Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Thornton
North Suburban Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-451-7800

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Rehoboth Beach
Beebe Health Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Jacksonville
University of Florida Health Science Center - Jacksonville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-254-7581
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Tampa
Moffitt Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-946-7447
Savannah
Memorial Health University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Post Falls
Kootenai Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Site Public Contact
Phone: 312-864-5204
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357

Indiana

South Bend
Memorial Hospital of South Bend
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-284-7370

Iowa

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
Email: clinicaltrials@sfmc-gi.org
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225
Sioux City
Siouxland Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 712-252-9326
Email: HoopingarnerT@jencc.com

Kansas

Kansas City
University of Kansas Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu

Kentucky

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 502-562-3429

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maryland

Baltimore
Greater Baltimore Medical Center
Status: Active
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
Email: jhcccro@jhmi.edu

Massachusetts

Boston
Boston Medical Center
Status: Temporarily closed to accrual
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: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Ascension Saint John Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Flint
Genesys Hurley Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Kalamazoo
West Michigan Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Livonia
Saint Mary Mercy Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Pontiac
Saint Joseph Mercy Oakland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Port Huron
Lake Huron Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Saginaw
Ascension Saint Mary's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Warren
Saint John Macomb-Oakland Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

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

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: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
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: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Montana

Billings
Billings Clinic Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
Alegent Health Bergan Mercy Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

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
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: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 973-729-7001

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Bay Shore
Northwell Health Imbert Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 516-734-8896
Brooklyn
Maimonides Medical Center
Status: Temporarily 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
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
Email: cancerclinicaltrials@med.unc.edu

Ohio

Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Columbus
Ohio State University Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Elyria
Mercy Cancer Center-Elyria
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Parma
University Hospitals Parma Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Salem
UH Seidman Cancer Center at Salem Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
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
Email: clinicaltrials@ucphysicians.com
Wooster
Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 330-375-4221

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Oregon Health and Science University
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
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
Email: klitchfield@PINNACLEHEALTH.org
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
Lewistown
Lewistown Hospital
Status: Active
Contact: Site Public Contact
Phone: 717-242-7703
Email: HemonCCTrials@geisinger.edu
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: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Philadelphia
Fox Chase Cancer Center
Status: Active
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
Email: HemonCCTrials@geisinger.edu
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org

South Carolina

Charleston
Medical University of South Carolina
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Greenville
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greer
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org

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

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
MD Anderson in Katy
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
Nassau Bay
MD Anderson League City
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
Sugar Land
MD Anderson in Sugar Land
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
The Woodlands
MD Anderson in The Woodlands
Status: Active
Contact: Site Public Contact
Phone: 866-632-6789
Email: askmdanderson@mdanderson.org

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 801-855-4100
Email: officeofresearch@imail.org
Logan
Logan Regional Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 435-716-6400
Email: officeofresearch@imail.org
Murray
Intermountain Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Provo
Utah Valley Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 801-357-7965
Email: officeofresearch@imail.org
Saint George
Dixie Medical Center Regional Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 801-933-6070
Email: officeofresearch@imail.org

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
Email: Stephanie.VanBebber@inova.org
Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Site Public Contact
Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org

Washington

Federal Way
Saint Francis Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
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
Email: susan.papenfuse@usoncology.com
PeaceHealth Southwest Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org

West Virginia

Morgantown
West Virginia University Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: Active
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
Email: ncorp@aurora.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay Oncology at Saint Vincent Hospital
Status: Active
Contact: Eva N. Christensen
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Kenosha
Aurora Cancer Care-Kenosha South
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
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
Email: ncorp@aurora.org
Milwaukee
Aurora Cancer Care-Milwaukee
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
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
Toronto
University Health Network-Princess Margaret Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-890-8000ext12725
Email: info.cr.chum@ssss.gouv.qc.ca
McGill University Department of Oncology
Status: Temporarily closed to accrual
Contact: George Shenouda
Phone: 514-934-1934ext42953
Email: evelyn.ortega@muhc.mcgill.ca
The Research Institute of the McGill University Health Centre (MUHC)
Status: Active
Contact: Site Public Contact
Phone: 514-934-1934ext48354
Email: evelyn.ortega@muhc.mcgill.ca

Saudi Arabia

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

Trial Objectives and Outline

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 & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Cristina Paguia Rodriguez

Trial IDs

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