International Prospective Registry on Local Treatment Approaches in MLS

Study Overview
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Brief Summary
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To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)

Detailed Description
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In order to confirm the promising results of the 36 Gy dose level in the DOREMY trial (NCT02106312) and to compare outcome with other local treatment approaches.

Official Title
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International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas

Conditions
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Myxoid Liposarcoma

Intervention / Treatment
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* Procedure: Surgery
* Radiation: Preoperative RT 36Gy
* Radiation: Preoperative RT 50Gy
* Radiation: Postoperative RT 50-66Gy
* Radiation: RT 36Gy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11) ECOG PS 0-2 Written informed consent to share coded information in this international Registry Exclusion Criteria: Prior radiotherapy to the target area Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>MLS patients managed by surgery only | Procedure: Surgery<br>* Surgery<br>|
| Cohort B<br>MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery | Procedure: Surgery<br>* Surgery<br>Radiation: Preoperative RT 36Gy<br>* Preoperative radiotherapy to 36Gy (equivalent)<br>|
| Cohort C<br>MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery | Procedure: Surgery<br>* Surgery<br>Radiation: Preoperative RT 50Gy<br>* Preoperative radiotherapy to 50Gy (equivalent)<br>|
| Cohort D<br>MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent) | Procedure: Surgery<br>* Surgery<br>Radiation: Postoperative RT 50-66Gy<br>* Postoperative radiotherapy to 50-66Gy (equivalent)<br>|
| Cohort E<br>MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent) | Radiation: RT 36Gy<br>* Definitive radiotherapy to 36Gy (equivalent)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival | Survival from surgery to local recurrence (event) or last follow-up | From surgery to the end of at least 5 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complications | Any wound complication requiring intervention | From surgery to 6 months of follow-up | 
| Late toxicity | Any grade ≥2 late (radiation-induced) toxicity according to CTCAE v5.0 toxicity criteria | From 3 months after surgery to the end of at least 5 years of follow-up |