Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma

Status: Recruiting
Phase: Phase 3
Diagnosis: Sarcoma
NCT ID: NCT01344018 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-301

 

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School

Overall PI:
Chandrajit Raut, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Melissa Hohos, mhohos@partners.org
Dana-Farber Cancer Institute: Mark Morley, mmorley@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist, imaging-guided or surgical biopsy, including the following: - Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis - Sarcoma not originated from bone structure, abdominal, or gynecological viscera - Unifocal tumor (not multifocal disease) - Absence of extension through the sciatic notch or across the diaphragm - The following histological sub-types are not allowed: - Gastrointestinal stromal tumor (GIST) - Rhabdomyosarcomas - Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma - Osteosarcoma or chondrosarcoma - Aggressive fibromatosis - Sarcomatoid or metastatic carcinoma - No metastatic disease - Untreated disease - Tumor must be operable and suitable for radiotherapy, based on the following criteria: - Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist, and radiologist (anticipated macroscopically complete resection, R0/R1 resection) - No surgery anticipated to be R2 on the CT scan before randomization - Must have American Society of Anesthesiologist (ASA) score ≤ 2 - None of the following unresectable criteria: - Involvement of superior mesenteric artery - Involvement of aorta - Involvement of bone - Must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (with IV and PO contrast) or MRI (with IV contrast) PATIENT CHARACTERISTICS: - WHO performance status 0-2 - WBC ≥ 2,500/mm^3 - Platelet count ≥ 80,000/mm^3 - Total bilirubin < 1.5 times the upper limit normal - Calculated creatinine clearance normal - Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram - Adequate cardiac function (NYHA class I-II) - ECG normal (without clinically significant abnormalities) - No history of any of the following disorders: - Bowel obstruction - Mesenteric ischemia - Severe chronic inflammatory bowel disease - Negative pregnancy test - Not pregnant or nursing concurrently and for at least 1 month after the surgery - Fertile patients must use effective contraception during the study treatment period and for at least 1 month after the surgery - No co-existing malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix - No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: - No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy - No prior abdominal or pelvic irradiation for another prior malignancy or other disease - No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted therapy) - No postoperative radiotherapy planned
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