A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years
From randomization to 2 years.
No
Cristina P. Rodriguez, MD
Principal Investigator
OHSU Knight Cancer Institute
United States: Federal Government
RTOG 1008
NCT01220583
January 2011
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Swedish Medical Center | Englewood, Colorado 80110 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
UMDNJ University Hospital | Newark, New Jersey 07103 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
McKee Medical Center | Loveland, Colorado 80539 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Beth Israel Medical Center - Petrie Division | New York, New York 10003-3803 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
William W. Backus Hospital | Norwich, Connecticut 06360 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Stanford Cancer Center | Stanford, California 94305-5824 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Duke Cancer Institute | Durham, North Carolina 27710 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow, New York 10591 |
Rocky Mountain Cancer Centers - Aurora | Aurora, Colorado 80012 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |
Coastal Cancer Center at Sentara Virginia Beach General Hospital | Virginia Beach, Virginia 23454 |
Memorial Sloan-Kettering Cancer Center - Basking Ridge | Basking Ridge, New Jersey 07920 |
Memorial Sloan-Kettering Cancer Center - Rockville Centre | Rockville Centre, New York 11570 |