Clinical Trial: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
Brief Summary: To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.
Detailed Summary:
- A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.
- Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.
Sponsor: The Netherlands Cancer Institute
Current Primary Outcome: The Pathological description of the percentage necrosis after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study) [ Time Frame: The percentage of necrosis will be pathologically assessed on the resection specimen; this procedure will take on average 7-10 working days. After surgery, patients will be followed up to 10 years. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The Netherlands Cancer Institute
Dates:
Date Received: March 6, 2014
Date Started: November 2010
Date Completion: July 2018
Last Updated: September 19, 2016
Last Verified: September 2016
