A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS)
OBJECTIVES:
Primary
- Compare progression-free survival of patients with primary soft tissue sarcoma of the
retroperitoneum or pelvis treated with surgery with vs without preoperative
radiotherapy.
Secondary
- Compare the toxicity and complications associated with these regimens in these
patients.
- Compare the rate of microscopically complete surgical resection in patients treated
with these regimens.
- Compare the overall survival rate of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
grade (low [G1] vs intermediate [G2] vs high [G3/4]), tumor size (< 15 cm vs ≥ 15 cm), and
tumor histology (liposarcoma vs non-liposarcoma). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients undergo surgery.
- Arm II: Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5
weeks. Within 28-63 days after the completion of radiotherapy, patients undergo
surgery.
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually
for 5 years.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this
study within 4.5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Progression-free survival at 5 years
No
Peter W.T. Pisters, MD
Study Chair
M.D. Anderson Cancer Center
United States: Federal Government
CDR0000387803
NCT00091351
August 2004
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
George Washington University Medical Center | Washington, District of Columbia 20037 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
LDS Hospital | Salt Lake City, Utah 84143 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Fox Chase-Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
American Fork Hospital | American Fork, Utah 84003 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Phoebe Cancer Center at Phoebe Putney Memorial Hospital | Albany, Georgia 31702 |
U.T. Cancer Institute at University of Tennessee Medical Center | Knoxville, Tennessee 37920-2911 |
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields, Illinois 60461 |