Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma o… (NCT00091351) | Clinical Trial Compass
CompletedPhase 3
Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis
United States370 participantsStarted 2004-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …