A Prospective Randomized Trial of Pre-Operative IMRT+Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma

Inclusion Criteria: Patients with primary retroperitoneal/pelvic soft tissue sarcoma. Gross total resection (RO or R1) must be feasible. No prior chemotherapy, immunotherapy or radiotherapy is allowable. Patients should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with hospital policy. Karnofsky performance status of >= 70 % No other concurrent chemotherapy, immunotherapy or radiotherapy is allowable. Adequate organ function defined as follows: absolute granulocytes >= 1,500/mm 3, platelets >= 150,000/mm 3, serum bilirubin <= 1.5 mg/dl, serum creatinine <= 1.5 mg/dl. Written informed consent (study specific) must be obtained from each patient prior to entering the study. Patients should be willing to be followed at Memorial Sloan-Kettering Cancer Center during the course of treatment and follow-up. Patients must be able to get IMRT radiotherapy at Memorial Sloan-Kettering Cancer Center Exclusion Criteria: Patients presenting with primary non-retroperitoneal soft tissue sarcoma or recurrent retroperitoneal sarcoma. Patients who are deemed unresectable by clinical/imaging criteria. Patients with histologic diagnosis of gastrointestinal stromal sarcoma, desmoplastic small round cell tumor, desmoid, Ewing's sarcoma, PNET, adenosarcoma, granular cell tumor, mesothelioma or rhabdomyosarcoma are excluded from the study. Patients with known metastatic disease, or those with radiologically evident metastases. Patients with clinically significant heart disease (NYHA Class III/IV), history of active angina or myocardial infarction within 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics or a history of clinically significant conduction system abnormality. Patients with any of the above conditions who are seen by a cardiologist at MSKCC and are found to be an acceptable risk for surgery will be allowed to participate in this study. Patients with any active concurrent malignancy other than non-melanoma skin cancers or carcinoma-in situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be eligible. Women who are pregnant. Patients currently participating in other clinical trials the requirements of which may preclude their complete involvement in this study Patients with serious intercurrent infections or non-malignant uncontrolled illnesses