Spots Global Cancer Trial Database for Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis
Official Title: A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS)
Study ID: NCT00091351
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy. PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
George Washington University Medical Center, Washington, District of Columbia, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West, Joliet, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Middletown Regional Hospital, Middletown, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Cleveland Clinic - Wooster, Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center, Bethlehem, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase-Temple Cancer Center, Philadelphia, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
U.T. Cancer Institute at University of Tennessee Medical Center, Knoxville, Tennessee, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
American Fork Hospital, American Fork, Utah, United States
Cottonwood Hospital Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah, United States
Dixie Regional Medical Center - East Campus, Saint George, Utah, United States
Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Peter Pisters, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
