Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis
NCT ID: NCT00091351
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2004-08-31
2006-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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surgery
Patients undergo surgery.
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.
conventional surgery
radiation + surgery
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.
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.
conventional surgery
radiation therapy
Interventions
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conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Anaplastic sarcoma
* Angiosarcoma
* Atypical lipomatous tumor (low-grade liposarcoma)
* Clear cell sarcoma
* Epithelioid sarcoma
* Fibrosarcoma
* Leiomyosarcoma
* Liposarcoma (all subtypes)
* Malignant fibrous histiocytoma
* Malignant peripheral nerve sheath tumor
* Myxofibrosarcoma
* Neurofibrosarcoma
* Spindle cell sarcoma
* Synovial sarcoma
* Unclassified sarcoma
* The following histologies are not eligible:
* Rhabdomyosarcoma
* Extraosseous Ewing's sarcoma
* Primitive neuroectodermal tumor
* Osteosarcoma
* Chondrosarcoma
* Aggressive fibromatosis (desmoid tumor)
* Gastrointestinal stromal tumor
* Sarcomatoid carcinoma
* Hemangiopericytoma
* Retroperitoneal sarcomas located predominantly in the retroperitoneum extending across the inguinal ligament into the abdominal wall are allowed provided that ≥ 90% of the tumor volume is located within the retroperitoneal space
* No bowel obstruction OR history of previous bowel obstruction attributed to retroperitoneal tumor
* Primary non-visceral retroperitoneal masses consistent with sarcoma allowed provided diagnoses of carcinoma, melanoma, and lymphoma are excluded by immunohistochemistry
* Measurable gross disease by abdominopelvic CT scan (with IV and oral contrast) or MRI (with IV contrast)
* Patients must have undergone radiotherapy consultation within the past 30 days to confirm the feasibility of preoperative external-beam radiotherapy
* Patients must have undergone surgical consultation within the past 30 days to confirm and document the feasibility of macroscopically complete resection
* No prior macroscopically incomplete (R2) resection (i.e., partial debulking or subtotal tumor resection with gross residual disease)
* No pelvic sarcoma extending through the sciatic notch
* No clinical or radiographic evidence of probable metastatic disease
* Equivocal pulmonary or liver lesion allowed provided the likelihood of metastatic disease is small
* No sarcoma arising from bone or any retroperitoneal viscus (except the kidney)
* No sarcoma extending across the diaphragm into the thorax
* No recurrent retroperitoneal tumor
* No multifocal disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1 OR
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 2,500/mm\^3
* Platelet count ≥ 80,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 2.5 times ULN
* Albumin normal\* NOTE: \*Higher levels allowed
Renal
* Creatinine normal
* BUN normal
* Functional kidney confirmed by intravenous pyelogram and/or differential renal isotope scan
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No other malignancy within the past 5 years (except effectively treated basal cell or squamous cell skin cancer) unless patient was curatively treated AND is at low risk for recurrence
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No concurrent chemotherapy for primary tumor
Radiotherapy
* No prior abdominal or pelvic irradiation
* No concurrent intraoperative or postoperative radiotherapy for primary tumor
Surgery
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Peter Pisters, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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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 D.C., 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
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, 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
Countries
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Other Identifiers
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ACOSOG-Z9031
Identifier Type: -
Identifier Source: secondary_id
CDR0000387803
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z9031
Identifier Type: -
Identifier Source: org_study_id
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