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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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherRTOG 1008
CDR0000686072, NCI-2013-00370, NCT01220583

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays 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 or by stopping them from dividing. 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.

PURPOSE: This randomized phase II trial is studying 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.

Further Study Information

OBJECTIVES:

Primary

  • Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors.
  • Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

Secondary

  • Compare the acute toxicities of these 2 adjuvant treatments.
  • Compare long-term efficacy results at 5 years and late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.
  • Investigate quality of life and patient-reported outcomes in patients enrolled in the study.
  • Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies.
  • Establish a Radiation Therapy Oncology Group (RTOG) baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: 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.
  • Arm II: Patients undergo 3D-CRT or IMRT as in arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes:
  • High-grade mucoepidermoid carcinoma
  • Salivary duct carcinoma
  • High-grade adenocarcinoma
  • 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 patients with salivary gland malignancies originating from the minor salivary glands
  • No patients with histologies other than high-grade mucoepidermoid carcinoma, high-grade adenocarcinoma, or salivary duct carcinoma

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Cristina P. RodriguezPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 Kirklin Clinic at Acton Road
 Sharon A Spencer Ph: 205-934-0309
 UAB Comprehensive Cancer Center
 Sharon A Spencer Ph: 205-934-0309
Arizona
  Phoenix
 Arizona Oncology - Deer Valley Center
 David G. Brachman Ph: 800-360-6371
  Scottsdale
 Arizona Oncology Services Foundation
 David G. Brachman Ph: 800-360-6371
California
  Auburn
 Auburn Radiation Oncology
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Carmichael
 Mercy Cancer Center at Mercy San Juan Medical Center
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Richard L Jennelle Ph: 323-865-0451
 Richard L Jennelle Ph: 323-865-0451
  Roseville
 Radiation Oncology Center - Roseville
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Sacramento
 Radiological Associates of Sacramento Medical Group, Incorporated
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Sue S Yom Ph: 877-827-3222
  Stanford
 Stanford Cancer Center
 Quynh-Thu X Le Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
  Vacaville
 Solano Radiation Oncology Center
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
Colorado
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Alan T Monroe Ph: 888-785-6789
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Adam Raben Ph: 302-733-6227
Florida
  Gainesville
 UF Health Cancer Center
 William M. Mendenhall Ph: 352-273-8675
  Email: trials@cancer.ufl.edu
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Rafael R Manon Ph: 321-841-7246
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Jonathan J Beitler Ph: 404-778-1868
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Samir Narayan Ph: 734-712-3456
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Samir V Sejpal Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Bahman Emami Ph: 708-226-4357
  Springfield
 Cancer Institute at St. John's Hospital
 Cathy L. Clausen Ph: 217-525-5666
  Email: diana.weyhenmeyer@st-johns.org
Indiana
  Goshen
 Center for Cancer Care at Goshen General Hospital
 James A. Wheeler Ph: 574-535-2858
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Des Moines
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Mark C Smith Ph: 800-237-1225
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Mahesh Kudrimoti Ph: 859-257-3379
  Louisville
 University of Louisville School of Medicine
 Shiao Y Woo Ph: 866-530-5516
Louisiana
  Baton Rouge
 Mary Bird Perkins Cancer Center - Baton Rouge
 Robert W Veith Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
  New Orleans
 Touro Infirmary
 Robert W Veith Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Marshall A. Levine Ph: 443-849-3706
Massachusetts
  Boston
 Boston University Cancer Research Center
 Minh T Truong Ph: 617-638-8265
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Samir Narayan Ph: 734-712-3456
 University of Michigan Comprehensive Cancer Center
 Avraham Eisbruch Ph: 800-865-1125
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Samir Narayan Ph: 734-712-3456
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Livonia
 St. Mary Mercy Hospital
 Samir Narayan Ph: 734-712-3456
  Pontiac
 St. Joseph Mercy Oakland
 Samir Narayan Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Samir Narayan Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Samir Narayan Ph: 734-712-3456
  Warren
 St. John Macomb Hospital
 Samir Narayan Ph: 734-712-3456
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Shankar P Giri Ph: 601-815-6700
Missouri
  Saint Louis
 Saint Louis University Cancer Center
 Bruce J. Walz Ph: 314-977-4440
Nebraska
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
Nevada
  Las Vegas
 Radiation Oncology Centers of Las Vegas - Downtown Location
 John Allan Ellerton Ph: 702-384-0013
New Jersey
  Newark
 UMDNJ University Hospital
 Sabin B Motwani Ph: 732-235-8675
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Voichita Bar Ad Ph: 215-955-6084
  Voorhees
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Lemuel S. Ariaratnam Ph: 888-847-8823
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Benny J. Liem Ph: 505-272-6972
New York
  Brooklyn
 Maimonides Cancer Center at Maimonides Medical Center
 Jay S Cooper Ph: 718-765-2500
  New York
 Mount Sinai Medical Center
 Richard Bakst Ph: 212-824-7320
  Email: jenny.figueroa@mssm.edu
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
  Syracuse
 SUNY Upstate Medical University Hospital
 Seung Shin Hahn Ph: 315-464-5476
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Bhishamjit S Chera Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  Cleveland
 Case Comprehensive Cancer Center
 David J Adelstein Ph: 866-223-8100
 Cleveland Clinic Taussig Cancer Center
 David J Adelstein Ph: 866-223-8100
  Medina
 Summa Health Center at Lake Medina
 Charles A Kunos Ph: 330-375-6101
  Middleburg Heights
 Southwest General Health Center
 David J Adelstein Ph: 866-223-8100
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Matthew C Solhjem Ph: 503-215-6412
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Ariel Lopez-Chavez Ph: 503-494-1080
  Email: trials@ohsu.edu
 Providence Cancer Center at Providence Portland Medical Center
 Matthew C Solhjem Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Matthew C Solhjem Ph: 503-215-6412
Pennsylvania
  Clairton
 UPMC Cancer Center at Jefferson Regional Medical Center
 James P Ohr Ph: 412-647-8073
  Greensburg
 UPMC Cancer Center - Arnold Palmer Pavilion
 James P Ohr Ph: 412-647-8073
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Heath B Mackley Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Moon Township
 UPMC - Moon
 James P Ohr Ph: 412-647-8073
  New Castle
 Jameson Memorial Hospital - North Campus
 James P Ohr Ph: 412-647-8073
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Thomas J Galloway Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Voichita Bar Ad Ph: 215-955-6084
 Radiation Therapy Oncology Group
 Cristina P Rodriguez Ph: 503-494-8534
  Email: rodrigcr@ohsu.edu
  Pittsburgh
 St. Clair Memorial Hospital Cancer Center
 James P Ohr Ph: 412-647-8073
 UPMC - Shadyside
 James P Ohr Ph: 412-647-8073
 UPMC Cancer Center at UPMC Passavant
 James P Ohr Ph: 412-647-8073
 UPMC Cancer Center at UPMC St. Margaret
 James P Ohr Ph: 412-647-8073
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Joshua D Hornig Ph: 843-792-9321
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
  Email: research@rcrh.org
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
 Kenneth J Niermann Ph: 800-811-8480
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Lucien A. Nedzi Ph: 214-648-7097
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Ehab Y. Hanna Ph: 713-792-3245
Utah
  Logan
 Logan Regional Hospital
 Vilija N Avizonis Ph: 801-507-3950
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 Vilija N Avizonis Ph: 801-507-3950
  Provo
 Utah Valley Regional Medical Center - Provo
 Vilija N Avizonis Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 Vilija N Avizonis Ph: 801-507-3950
  Salt Lake City
 Utah Cancer Specialists at UCS Cancer Center
 Vilija N Avizonis Ph: 801-507-3950
Virginia
  Hampton
 Sentara Cancer Institute at Sentara CarePlex Hospital
 Scott S Williams Ph: 757-388-2406
  Norfolk
 Sentara Cancer Institute at Sentara Norfolk General Hospital
 Scott S Williams Ph: 757-388-2406
  Virginia Beach
 Coastal Cancer Center at Sentara Virginia Beach General Hospital
 Scott S Williams Ph: 757-388-2406
Washington
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
 Southwest Washington Medical Center Cancer Center
 Matthew C Solhjem Ph: 503-215-6412
West Virginia
  Wheeling
 Schiffler Cancer Center at Wheeling Hospital
 Jon David Pollock Ph: 304-243-6442
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
 St. Mary's Hospital Medical Center - Green Bay
 James L Leenstra Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 James L Leenstra Ph: 920-433-8889
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Christopher J. Schultz Ph: 414-805-4380
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 James L Leenstra Ph: 920-433-8889
Canada
Alberta
  Edmonton
 Cross Cancer Institute at University of Alberta
 Rufus A Scrimger Ph: 780-432-8500
Ontario
  Sudbury
 Northeastern Ontario Regional Cancer Centre
 Adam K Andronowski Ph: 706-522-6237ext2401
  Email: japaquette@hrsrh.on.ca
  Toronto
 Princess Margaret Hospital
 John (Joon-Hyung) Kim Ph: 416-946-4501
  Email: clinical.trials@uhn.on.ca
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 Phuc Felix Nguyen-Tan Ph: 514-890-8000ext23611
  Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01220583
ClinicalTrials.gov processed this data on December 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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