International Prospective Registry on Local Treatment Approaches in MLS

The Netherlands Cancer Institute300 enrolled

Overview

To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Myxoid Liposarcoma

Interventions

SurgeryPROCEDURE

Surgery

Preoperative RT 36GyRADIATION

Preoperative radiotherapy to 36Gy (equivalent)

Preoperative RT 50GyRADIATION

Preoperative radiotherapy to 50Gy (equivalent)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Netherlands Cancer Institute

Amsterdam, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Local recurrence free survival

Survival from surgery to local recurrence (event) or last follow-up

Time frame: From surgery to the end of at least 5 years of follow-up

Secondary Outcomes

Wound complications

Any wound complication requiring intervention

Time frame: From surgery to 6 months of follow-up

Late toxicity

Any grade ≥2 late (radiation-induced) toxicity according to CTCAE v5.0 toxicity criteria

Time frame: From 3 months after surgery to the end of at least 5 years of follow-up

Central Contacts

Rick Haas, MD/PhD

CONTACT

+31 20 512 9111 r.haas@nki.nl

Jules Lansu, MD/PhD

CONTACT

+31 20 512 9111 j.lansu@nki.nl

Data from ClinicalTrials.gov

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