Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma
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.
Other: laboratory biomarker analysis
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)|
- Abdominal recurrence-free survival [ Designated as safety issue: No ]
- Acute toxicity profile of preoperative radiotherapy [ Designated as safety issue: Yes ]
- Perioperative complications [ Designated as safety issue: Yes ]
- Late complications [ Designated as safety issue: Yes ]
- Tumor response to preoperative radiotherapy [ Designated as safety issue: No ]
- Time to abdominal recurrence [ Designated as safety issue: No ]
- Metastasis-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
- To assess whether there is a difference in abdominal recurrence-free survival between retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone and those undergoing preoperative radiotherapy followed by curative-intent surgery.
- To assess whether there is a difference in metastasis-free survival, abdominal recurrence-free interval, and overall survival between these patients.
- To assess tumor response in patients undergoing preoperative radiotherapy.
- To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to institution and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgical resection of the tumor mass within 4 weeks following randomization.
- Arm II: Patients undergo 3-dimensional conformal radiation therapy (RT) or intensity-modulated RT within 8 weeks after randomization. RT continues 5 days a week for approximately 5.5 weeks. Patients undergo surgical resection of the tumor mass within 4-8 weeks after the completion of RT.
Tumor tissue, normal abdominal wall fat, and peripheral blood may be collected during surgery to identify new prognostic factors for translational research.
After completion of study therapy, patients are followed at day 60 post-surgery and every 6 months thereafter.
|Investigator:||Sylvie Bonvalot||Institut Gustave Roussy|
|Investigator:||Rick L. M. Haas, MD||The Netherlands Cancer Institute|