Dose Reduction of preoperative radiotherapy in myxoid liposarcoma

Phase 2

• Conditions: soft tissue mass; soft tissue sarcoma; 10010761; 10072990

• Registration Number: NL-OMON47519
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 73

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 (regiment 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.
3. ECOG PS 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 derivatives), coumarines (Sintrom ® and Marcoumar ®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients on consenting to the translational research part of the study; patient 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The induction of a pathological response after reduced RT dose</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>