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

Sarcoma Clinical Trial

Official title: Phase III Prospective Randomized Trial of Pre-Operative Intensity Modulated Radiation Therapy (IMRT) Plus Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma

Status Completed

Clinical Trial Summary

This is a phase III clinical trial for patients with potentially completely resectable primary retroperitoneal sarcoma. Patients who take part will be divided into two groups, a radiation therapy plus surgery group and a surgery alone group.

Patients in the radiation therapy plus surgery group will receive radiation treatments as an outpatient. Surgery to try to remove the remaining tumor will be done after the radiation treatments are completed.

Patients in the surgery alone group will have surgery to try to remove all tumor.

Clinical Trial Description

Primary Objective: To ascertain whether patients with completely resected (R0 + R1), primary retroperitoneal sarcoma who are randomized to pre-operative IMRT and surgery have a longer recurrence-free survival compared to patients randomized to treatment with surgery alone.

Secondary Objectives: To ascertain whether patients with completely resected (R0 + R1), primary retroperitoneal sarcoma randomized to pre-operative IMRT and surgery have longer overall survival compared to patients randomized to treatment with surgery alone.

• To compare the resectability rate between the two arms

• Determine the variability of NMR biochemical profiles and the variability of expression for genes/proteins involved in adipocyte differentiation, cell cycle control and apoptosis within different regions of the primary retroperitoneal sarcoma in patients treated with surgery alone and pre-operative radiotherapy.

• Analyze NMR biochemical patterns and expression patterns for genes/proteins involved in adipocyte differentiation, cell cycle control and apoptosis to identify markers that can provide an objective measure of sarcoma differentiation, proliferation, and apoptosis.

• Predict the response of sarcoma to radiation therapy and the risk of local recurrence, based on data derived from NMR biochemical and gene/protein expression patterns in patient tumors that recurred compared to those without recurrence.

• Determine if diffusion-weighted MRI early in course of radiation therapy can predict the ultimate pathologic response of sarcoma following resection and the risk of local recurrence.

• Analyze plasma levels of VEGF, FGF, Ang-1, Ang-2 and endostatin prior to and following therapy and correlate with treatment response, local and distant recurrence. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

• NCT number: NCT00131898
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 3
• Start date: May 2003
• Completion date: September 2005