NCT02106312

Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

* 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.

Conditions

• Myxoid Liposarcoma of Soft Tissue

Interventions

Type	Name	Description
RADIATION	dose reduction of preoperative radiotherapy in MLS	A: The primary sarcoma in case of non-metastatic disease for management is with curative intent (regime to be chosen=18 x 2 Gy) B: In case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 Gy in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes.

Timeline

• Start date: 2010-12-15
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2014-04-08
• Last updated: 2021-08-04

Locations

12 sites across 5 countries: United States, Denmark, Netherlands, Norway, United Kingdom