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

Basic Trial Information

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

Cristina P. Rodriguez

Principal Investigator

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Cen	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer	Ph: 858-822-5354
			Email: cancercto@ucsd.edu
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Cente	Ph: 323-865-0451
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer	Ph: 916-734-3089
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensi	Ph: 877-827-3222
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph: 650-498-7061
			Email: cctoffice@stanford.edu
Colorado
	Aurora
	Rocky Mountain Cancer Centers - Aurora
		Eduardo R. Pajon, MD	Ph: 303-399-8020 Ext.2261
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph: 303-938-5253
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph: 719-776-5275
	Denver
	Porter Adventist Hospital
		Eduardo R. Pajon, MD	Ph: 303-399-8020 Ext.2261
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020 Ext.2261
	Loveland
	McKee Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020 Ext.2261
	Thornton
	North Suburban Medical Center
		Eduardo R. Pajon, MD	Ph: 303-399-8020 Ext.2261
Connecticut
	Norwich
	William W. Backus Hospital
		Dennis E. Slater, MD	Ph: 860-886-8362
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph: 302-623-4450
Florida
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer C	Ph: 888-254-7581
	Orlando
	M.D. Anderson Cancer Center at Orlando
		Rafael R. Manon	Ph: 407-648-3800
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Clinical Trials Office - Winship Cancer Institute	Ph: 404-778-1900
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph: 208-367-7954
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph: 708-226-4357
	Springfield
	Cancer Institute at St. John's Hospital
		Cathy L. Clausen, MD	Ph: 765-646-8358
Indiana
	Goshen
	Center for Cancer Care at Goshen General Hospital
		Clinical Trials Office - Center for Cancer Care at Goshen Gene	Ph: 574-535-2858
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph: 515-239-2621
	Des Moines
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa M	Ph: 515-241-6727
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald B. Wender, MD, PhD	Ph: 712-252-0088
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of	Ph: 859-257-3379
	Louisville
	James Graham Brown Cancer Center at University of Louisville
		Shiao Y. Woo	Ph: 502-562-4158
Louisiana
	Baton Rouge
	Mary Bird Perkins Cancer Center - Baton Rouge
		Robert W. Veith	Ph: 225-767-0847
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Clinical Trials Office - Greater Baltimore Medical Center Canc	Ph: 443-849-3706
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive	Ph: 800-865-1125
	Pontiac
	St. Joseph Mercy Oakland
		Samir Narayan	Ph: 248-858-3612
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Samir Narayan	Ph: 810-985-1484
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph: 989-776-8411
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		P. G. Shankar Giri	Ph: 601-984-5590
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Tien-Shew W. Huang	Ph: 402-354-5890
New Jersey
	Basking Ridge
	Memorial Sloan-Kettering Cancer Center - Basking Ridge
		David M. Kushner	Ph: 908-542-3000
	Newark
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		A. Dolly Razdan	Ph: 973-972-4300
	Sparta
	Frederick R. and Betty M. Smith Cancer Treatment Center
		Voichita Bar Ad	Ph: 973-726-4180
	Voorhees
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Lemuel S. Ariaratnam, MD	Ph: 609-261-7074
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Cente	Ph: 505-272-6972
New York
	Commack
	Memorial Sloan-Kettering Cancer Center
		David M. Kushner	Ph: 212-639-8895
	New York
	Beth Israel Medical Center - Petrie Division
		Clinical Trials Office - Beth Israel Medical Center - Petrie D	Ph: 212-844-6286
	Rochester
	Highland Hospital of Rochester
		Yuhchyau Chen	Ph: 585-473-2200
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Yuhchyau Chen	Ph: 585-275-5345
	Rockville Centre
	Memorial Sloan-Kettering Cancer Center - Rockville Centre
		David M. Kushner	Ph: 516-256-3651
	Sleepy Hollow
	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
		David M. Kushner	Ph: 914-366-3000
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Cente	Ph: 877-668-0683
		Clinical Trials Office	Ph: 919-966-4432
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph: 888-275-3853
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph: 330-375-6101
	Barberton
	Barberton Citizens Hospital
		William F. Demas, MD	Ph: 330-375-3557
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Kevin P. Redmond, MD	Ph: 513-584-9089
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph: 800-641-2422
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente	Ph: 866-223-8100
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph: 866-627-7616
			Email: Jamesline@osumc.edu
	Mentor
	Lake/University Ireland Cancer Center
		David J. Adelstein	Ph: 440-205-5755
	Middleburg Heights
	Southwest General Health Center
		David J. Adelstein	Ph: 440-816-8000
	Salem
	Cancer Care Center, Incorporated
		William F. Demas, MD	Ph: 330-375-3557
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph: 419-824-1842
	Toledo
	St. Anne Mercy Hospital
		Rex B. Mowat	Ph: 419-407-2663
	West Chester
	Precision Radiotherapy at University Pointe
		Kevin P. Redmond, MD	Ph: 513-584-9089
	Wooster
	Cancer Treatment Center
		Clinical Trials Office - Cancer Treatment Center	Ph: 330-375-4221
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Terence S. Herman	Ph: 405-271-6822
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Matthew C. Solhjem	Ph: 503-513-3300
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Hea	Ph: 503-494-1080
			Email: trials@ohsu.edu
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providenc	Ph: 503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph: 503-215-6412
Pennsylvania
	Hershey
	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Hershey Cancer Institute a	Ph: 717-531-3779
			Email: CTO@hmc.psu.edu
	Paoli
	Cancer Center of Paoli Memorial Hospital
		Clinical Trials Office - Cancer Center of Paoli Memorial Hospi	Ph: 610-648-1637
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphi	Ph: 215-728-4790
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer	Ph: 215-955-6084
	Wynnewood
	Lankenau Cancer Center at Lankenau Hospital
		Paul B. Gilman, MD	Ph: 610-645-2000
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical Uni	Ph: 843-792-9321
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Michael J. Swartz	Ph: 605-719-2360
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph: 800-811-8480
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center a	Ph: 866-460-4673
		Clinical Trials Office	Ph: 214-648-7097
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the U	Ph: 713-792-3245
Virginia
	Norfolk
	Sentara Cancer Institute at Sentara Norfolk General Hospital
		Clinical Trials Office - Sentara Cancer Institute at Sentara N	Ph: 757-388-2406
	Virginia Beach
	Coastal Cancer Center at Sentara Virginia Beach General Hospital
		Scott S. Williams	Ph: 757-395-8686
Washington
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Matthew C. Solhjem	Ph: 360-944-9889
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Gregory M. Cooley, MD	Ph: 414-433-8184
	St. Mary's Hospital Medical Center - Green Bay
		Gregory M. Cooley, MD	Ph: 414-433-8184
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer	Ph: 920-433-8889
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbo	Ph: 608-262-5223
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Gregory M. Cooley, MD	Ph: 414-433-8184
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer C	Ph: 414-805-4380
	Sturgeon Bay
	Door County Cancer Center at Door County Memorial Hospital
		Gregory M. Cooley, MD	Ph: 414-433-8184
Canada
Alberta
	Edmonton
	Cross Cancer Institute at University of Alberta
		Rufus A. Scrimger	Ph: 780-432-8771
Ontario
	London
	London Regional Cancer Program at London Health Sciences Centre
		Varagur M. Venkatesan	Ph: 519-685-8615
	Sudbury
	Northeastern Ontario Regional Cancer Centre
		Adam K. Andronowski	Ph: 705-522-6237
	Toronto
	Princess Margaret Hospital
		John (Joon-Hyung) Kim	Ph: 416-946-2811
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Phuc Felix Nguyen-Tan	Ph: 514-281-6000
	McGill Cancer Centre at McGill University
		Khalil Sultanem	Ph: 514-398-1444
Saudi Arabia
	Riyadh
	King Faisal Specialist Hospital and Research Center
		Nasser M. Al Rajhi	Ph: 966-3-464-7272 ext. 23940

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01220583
Information obtained from ClinicalTrials.gov on June 13, 2013