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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase III, Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overRTOG 1008
NCI-2013-00370, CDR0000686072, NCI-2011-00795, NCT01220583

Trial Description

Summary

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 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.

Further Study Information

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) 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 radiation therapy (IMRT) 5 days a week for 6-6.5 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 or IMRT 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.

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

Platelets >= 100,000 cells/mm^3

Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 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

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Cristina Paguia Rodriguez, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

The Kirklin Clinic at Acton Road

Sharon A. Spencer
Ph: 205-934-0309

Sharon A. Spencer
Principal Investigator

University of Alabama at Birmingham Cancer Center

Sharon A. Spencer
Ph: 205-934-0309

Sharon A. Spencer
Principal Investigator

California
La Jolla

UC San Diego Moores Cancer Center

Loren K. Mell
Ph: 858-822-5354
Email: cancercto@ucsd.edu

Loren K. Mell
Principal Investigator

Palo Alto

Stanford Cancer Institute

Quynh-Thu Xuan Le
Ph: 650-498-7061
Email: clinicaltrials@med.stanford.edu

Quynh-Thu Xuan Le
Principal Investigator

Delaware
Newark

Christiana Care Health System-Christiana Hospital

Adam Raben
Ph: 302-733-6227

Adam Raben
Principal Investigator

Helen F Graham Cancer Center

Adam Raben
Ph: 302-733-6227

Adam Raben
Principal Investigator

Rehoboth Beach

Beebe Health Campus

Adam Raben
Ph: 302-733-6227

Adam Raben
Principal Investigator

Florida
Orlando

UF Cancer Center at Orlando Health

Rafael Ricardo Manon
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Rafael Ricardo Manon
Principal Investigator

Tampa

Moffitt Cancer Center

Jimmy J. Caudell
Ph: 800-456-7121
Email: canceranswers@moffitt.org

Jimmy J. Caudell
Principal Investigator

Georgia
Atlanta

Emory University Hospital Midtown

Jonathan Jay Beitler
Ph: 404-778-1868

Jonathan Jay Beitler
Principal Investigator

Emory University/Winship Cancer Institute

Jonathan Jay Beitler
Ph: 404-778-1868

Jonathan Jay Beitler
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Illinois
Maywood

Loyola University Medical Center

Mehee Choi
Ph: 708-226-4357

Mehee Choi
Principal Investigator

Iowa
Des Moines

Iowa Methodist Medical Center

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator

Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

Kentucky
Louisville

The James Graham Brown Cancer Center at University of Louisville

Shiao Y. Woo
Ph: 866-530-5516

Shiao Y. Woo
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

University of Michigan Comprehensive Cancer Center

Avraham Eisbruch
Ph: 800-865-1125

Avraham Eisbruch
Principal Investigator

Detroit

Henry Ford Hospital

Eleanor M. Walker
Ph: 313-916-1784

Eleanor M. Walker
Principal Investigator

Saint John Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Sunil Nagpal
Ph: 269-373-7458

Sunil Nagpal
Principal Investigator

Livonia

Saint Mary Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Pontiac

Saint Joseph Mercy Oakland

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Saginaw

Saint Mary's of Michigan

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Shankar P. G. Giri
Ph: 601-815-6700

Shankar P. G. Giri
Principal Investigator

Montana
Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Omaha

Nebraska Methodist Hospital

Tien-Shew William Huang
Ph: 402-354-5144

Tien-Shew William Huang
Principal Investigator

New Jersey
Basking Ridge

Memorial Sloan Kettering Cancer Center at Basking Ridge

Nancy Y. Lee
Ph: 212-639-7202

Nancy Y. Lee
Principal Investigator

New York
Commack

Memorial Sloan Kettering Cancer Center Commack

Nancy Y. Lee
Ph: 212-639-7202

Nancy Y. Lee
Principal Investigator

New York

Memorial Sloan-Kettering Cancer Center

Nancy Y. Lee
Ph: 212-639-7202

Nancy Y. Lee
Principal Investigator

Rochester

University of Rochester

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

Rockville Centre

Memorial Sloan-Kettering Cancer Center Rockville Centre

Nancy Y. Lee
Ph: 212-639-7202

Nancy Y. Lee
Principal Investigator

Sleepy Hollow

Memorial Sloan-Kettering Cancer Center Sleepy Hollow

Nancy Y. Lee
Ph: 212-639-7202

Nancy Y. Lee
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Seung Shin Hahn
Ph: 315-464-5476

Seung Shin Hahn
Principal Investigator

North Carolina
Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Bhishamjit S. Chera
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Bhishamjit S. Chera
Principal Investigator

Ohio
Cincinnati

University of Cincinnati

Kevin Patrick Redmond
Ph: 513-558-4553
Email: uchealthnews@uc.edu

Kevin Patrick Redmond
Principal Investigator

Cleveland

Case Western Reserve University

David J. Adelstein
Ph: 866-223-8100

David J. Adelstein
Principal Investigator

Cleveland Clinic Foundation

David J. Adelstein
Ph: 866-223-8100

David J. Adelstein
Principal Investigator

Columbus

Ohio State University Comprehensive Cancer Center

Virginia M. Diavolitsis
Ph: 800-293-5066
Email: Jamesline@osumc.edu

Virginia M. Diavolitsis
Principal Investigator

Elyria

Mercy Cancer Center-Elyria

David J. Adelstein
Ph: 866-223-8100

David J. Adelstein
Principal Investigator

Middleburg Heights

Southwest General Health Center Ireland Cancer Center

David J. Adelstein
Ph: 866-223-8100

David J. Adelstein
Principal Investigator

Parma

University Hospitals Parma Medical Center

David J. Adelstein
Ph: 866-223-8100

David J. Adelstein
Principal Investigator

West Chester

University Pointe

Kevin Patrick Redmond
Ph: 513-558-4553
Email: uchealthnews@uc.edu

Kevin Patrick Redmond
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Terence S. Herman
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Terence S. Herman
Principal Investigator

Oregon
Clackamas

Clackamas Radiation Oncology Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Portland

Providence Portland Medical Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Providence Saint Vincent Medical Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Pennsylvania
Greensburg

UPMC Cancer Centers - Arnold Palmer Pavilion

James Paul Ohr
Ph: 412-647-8073

James Paul Ohr
Principal Investigator

Moon Township

UPMC-Coraopolis/Heritage Valley Radiation Oncology

James Paul Ohr
Ph: 412-647-8073

James Paul Ohr
Principal Investigator

Paoli

Paoli Memorial Hospital

Albert S. DeNittis
Ph: 484-476-2649
Email: ewend@mlhs.org

Albert S. DeNittis
Principal Investigator

Philadelphia

Thomas Jefferson University Hospital

Voichita Bar Ad
Ph: 215-955-6084

Voichita Bar Ad
Principal Investigator

Pittsburgh

UPMC-Passavant Hospital

James Paul Ohr
Ph: 412-647-8073

James Paul Ohr
Principal Investigator

UPMC-Saint Clair Hospital Cancer Center

James Paul Ohr
Ph: 412-647-8073

James Paul Ohr
Principal Investigator

UPMC-Saint Margaret

James Paul Ohr
Ph: 412-647-8073

James Paul Ohr
Principal Investigator

UPMC-Shadyside Hospital

James Paul Ohr
Ph: 412-647-8073

James Paul Ohr
Principal Investigator

Wynnewood

Lankenau Medical Center

Albert S. DeNittis
Ph: 484-476-2649
Email: ewend@mlhs.org

Albert S. DeNittis
Principal Investigator

South Carolina
Charleston

Medical University of South Carolina

Joshua David Hornig
Ph: 843-792-9321

Joshua David Hornig
Principal Investigator

Greenville

Greenville Health System Cancer Institute-Eastside

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Faris

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Texas
Dallas

UT Southwestern/Simmons Cancer Center-Dallas

Lucien Alexander Nedzi
Ph: 214-648-7097

Lucien Alexander Nedzi
Principal Investigator

Houston

M D Anderson Cancer Center

Ehab Y. Hanna
Ph: 713-792-3245

Ehab Y. Hanna
Principal Investigator

Utah
American Fork

American Fork Hospital / Huntsman Intermountain Cancer Center

Vilija N. Avizonis
Ph: 801-507-3950

Vilija N. Avizonis
Principal Investigator

Logan

Logan Regional Hospital

Vilija N. Avizonis
Ph: 801-507-3950

Vilija N. Avizonis
Principal Investigator

Murray

Intermountain Medical Center

Vilija N. Avizonis
Ph: 801-507-3950

Vilija N. Avizonis
Principal Investigator

Provo

Utah Valley Regional Medical Center

Vilija N. Avizonis
Ph: 801-507-3950

Vilija N. Avizonis
Principal Investigator

Saint George

Dixie Medical Center Regional Cancer Center

Vilija N. Avizonis
Ph: 801-507-3950

Vilija N. Avizonis
Principal Investigator

Salt Lake City

Utah Cancer Specialists-Salt Lake City

Vilija N. Avizonis
Ph: 801-507-3950

Vilija N. Avizonis
Principal Investigator

Washington
Vancouver

PeaceHealth Southwest Medical Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Wisconsin
Green Bay

Green Bay Oncology at Saint Vincent Hospital

Barbi L. Kaplan-Frenkel
Ph: 800-432-6049

Barbi L. Kaplan-Frenkel
Principal Investigator

Saint Mary's Hospital

Barbi L. Kaplan-Frenkel
Ph: 800-432-6049

Barbi L. Kaplan-Frenkel
Principal Investigator

Saint Vincent Hospital

Barbi L. Kaplan-Frenkel
Ph: 800-432-6049

Barbi L. Kaplan-Frenkel
Principal Investigator

Madison

University of Wisconsin Hospital and Clinics

Paul Maurice Harari
Ph: 877-405-6866

Paul Maurice Harari
Principal Investigator

Milwaukee

Froedtert and the Medical College of Wisconsin

Christopher J. Schultz
Ph: 414-805-4380

Christopher J. Schultz
Principal Investigator

Sturgeon Bay

Door County Cancer Center

Barbi L. Kaplan-Frenkel
Ph: 800-432-6049

Barbi L. Kaplan-Frenkel
Principal Investigator

Canada

Alberta
Edmonton

Cross Cancer Institute

Rufus Arni Scrimger
Ph: 780-432-8500

Rufus Arni Scrimger
Principal Investigator

Ontario
Toronto

University Health Network-Princess Margaret Hospital

John (Joon-Hyung) Kim
Ph: 416-946-4501
Email: clinical.trials@uhn.on.ca

John (Joon-Hyung) Kim
Principal Investigator

Quebec
Montreal

McGill University Department of Oncology

George Shenouda
Ph: 514-934-1934extn42953
Email: evelyn.ortega@muhc.mcgill.ca

George Shenouda
Principal Investigator

Saudi Arabia

Riyadh

King Faisal Specialist Hospital and Research Centre

Nasser M. Al-Rajhi
Ph: 011-966-1-464-7272 ext 38005

Nasser M. Al-Rajhi
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01220583

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.