Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult alveolar soft-part sarcoma, adult angiosarcoma, adult epithelioid sarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, adult malignant fibrous histiocytoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary soft tissue sarcoma of the retroperitoneum or pelvis (e.g., iliac fossa) The following histologies are eligible: Alveolar soft part sarcoma 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
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- City of Hope Comprehensive Cancer Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- George Washington University Medical Center
- University of Florida Shands Cancer Center
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Rush-Copley Cancer Care Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Joliet Oncology Hematology Associates, Limited - West
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Holden Comprehensive Cancer Center at University of Iowa
- James Graham Brown Cancer Center at University of Louisville
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Cancer Research Center at Boston Medical Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital
- Roswell Park Cancer Institute
- Blumenthal Cancer Center at Carolinas Medical Center
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
- Cleveland Clinic Taussig Cancer Center
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Cancer Institute at Oregon Health and Science University
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- St. Luke's Hospital Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase-Temple Cancer Center
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- U.T. Cancer Institute at University of Tennessee Medical Center
- CCOP - Scott and White Hospital
- American Fork Hospital
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- University Cancer Center at University of Washington Medical Center
- Medical College of Wisconsin Cancer Center
- Cross Cancer Institute at University of Alberta
- CancerCare Manitoba
- London Regional Cancer Program at London Health Sciences Centre
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
surgery
radiation + 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.
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.