Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

Myxoid Liposarcoma of Soft Tissue Clinical Trial

— DOREMY  

Official title:

Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02106312
• Other study ID #: N10DMY
• Secondary ID: 2588
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 15, 2010
• Est. completion date: December 15, 2021

Study information

• Verified date: June 2020
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age above or equal to 18 years

2. 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).

3. ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2

4. 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.

5. Written informed consent

Exclusion Criteria:

1. Prior radiotherapy to the target area.

2. 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.)

3. Pregnancy -

Related Conditions & MeSH terms

• Liposarcoma
• Liposarcoma, Myxoid
• Myxoid Liposarcoma of Soft Tissue

Intervention

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.

Locations

Country	Name	City	State
Denmark	University Hospital Aarhus	Aarhus
Netherlands	Academisch Medisch centrum	Amsterdam
Netherlands	The Netherlands Cancer Institute	Amsterdam	Noord Holland
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Maastro Clinic	Maastricht
Netherlands	Radboud umc	NIjmegen
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
United Kingdom	Royal Marsden Hospital	London
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Harvard Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Countries where clinical trial is conducted

United States,  Denmark,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.