Phase III Prospective Randomized Trial of Pre-Operative Intensity Modulated Radiation Therapy (IMRT) Plus Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Samuel Singer, M.D
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
03-050
NCT00131898
May 2003
September 2005
Name | Location |
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Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |