Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

Status unconfirmed · Phase 2

Conditions studied: Myxoid Liposarcoma of Soft Tissue

In brief

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.

Key facts

Study ID

NCT02106312

Run by

The Netherlands Cancer Institute

People needed

80

Starts

2010-12-15

Expected to finish

2021-12-15

Last updated by the study team

2021-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 -

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Harvard Cancer Center — Boston, Massachusetts, United States
• University Hospital Aarhus — Aarhus, Denmark
• The Netherlands Cancer Institute — Amsterdam, North Holland, Netherlands
• Academisch Medisch centrum — Amsterdam, Netherlands
• Universitair Medisch Centrum Groningen — Groningen, Netherlands
• Leids Universitair Medisch Centrum — Leiden, Netherlands
• Maastro Clinic — Maastricht, Netherlands
• Radboud umc — Nijmegen, Netherlands
• Haukeland University Hospital — Bergen, Norway
• Oslo University Hospital — Oslo, Norway
• Royal Marsden Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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