Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131898
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2005-08-17
Brief Title:
A Prospective Randomized Trial of Pre-Operative IMRTSurgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
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
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 genesproteins 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 genesproteins 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 geneprotein 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
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 genesproteins 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 genesproteins 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 geneprotein 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None