Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
- Conditions
- Myxoid Liposarcoma of Soft Tissue
- Interventions
- Radiation: dose reduction of preoperative radiotherapy in MLS
- Registration Number
- NCT02106312
- Lead Sponsor
- The Netherlands Cancer Institute
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Age above or equal to 18 years
- Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen 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 (see paragraph 10 for radiobiological considerations).
- ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
- Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
- Written informed consent
- Prior radiotherapy to the target area.
- Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
- Pregnancy -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation dose reduction of preoperative radiotherapy in MLS Dose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY.
- Primary Outcome Measures
Name Time Method The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study) The percentage of pathological responses 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Royal Marsden Hospital
🇬🇧London, United Kingdom
The Netherlands Cancer Institute
🇳🇱Amsterdam, Noord Holland, Netherlands
Harvard Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University Hospital Aarhus
🇩🇰Aarhus, Denmark
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Academisch Medisch centrum
🇳🇱Amsterdam, Netherlands
Maastro Clinic
🇳🇱Maastricht, Netherlands
Oslo University Hospital
🇳🇴Oslo, Norway
Radboud umc
🇳🇱NIjmegen, Netherlands
Haukeland University Hospital
🇳🇴Bergen, Norway