International Prospective Registry on Local Treatment Approaches in MLS

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ClinicalTrials.gov Identifier: NCT04699292

Recruitment Status : Recruiting

First Posted : January 7, 2021

Last Update Posted : August 30, 2022

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Radboud University Medical Center

Maastro Clinic, The Netherlands

University Medical Center Groningen

Leiden University Medical Center

Vienna General Hospital

M.D. Anderson Cancer Center

University Hospital, Antwerp

Universitetssykehus

Haukeland University Hospital

Universitäts-Frauenklinik Graz

University Hospital Heidelberg

Mayo Clinic

Aarhus University Hospital

National Cancer Center, Japan

Princess Margaret Hospital, Canada

MOUNT SINAI HOSPITAL

University of Sydney

Institute for Cancer Research and treatment

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Institut Curie

ANZSA (Australia and New Zealand Sarcoma Association)

Information provided by (Responsible Party):

The Netherlands Cancer Institute

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Myxoid Liposarcoma	Procedure: Surgery Radiation: Preoperative RT 36Gy Radiation: Preoperative RT 50Gy Radiation: Postoperative RT 50-66Gy Radiation: RT 36Gy

Detailed Description:

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 Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	300 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	5 Years
Official Title:	International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas
Actual Study Start Date :	January 18, 2021
Estimated Primary Completion Date :	January 2031
Estimated Study Completion Date :	January 2031

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Liposarcoma Myxoid Liposarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

Local recurrence free survival [ Time Frame: From surgery to the end of at least 5 years of follow-up ]
Survival from surgery to local recurrence (event) or last follow-up

Secondary Outcome Measures :

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

Other Outcome Measures:

Patient-Reported Outcome Measures (PROMs) [ Time Frame: From baseline visit to the end of 5 years of follow-up ]
PRO-CTCAE Item Library; relevant questions from the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)
Health-Related Quality of Life (HRQoL) [ Time Frame: From baseline visit to the end of 5 years of follow-up ]
EORTC QLQ-C30; 30-item HRQoL questionnaire; EORTC Items Library; 3 questions to assess some radiotherapy-specific HRQoL; EQ5D-5L; descriptive system for measurement of health; iMCQ; relevant items from the Medical Consumption Questionnaire (iMCQ) to assess medical consumption; PRODISQ; PROductivity and DISease Questionnaire to assess all relevant aspects of the relationship between health and productivity;

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with Myxoid Liposarcoma (MLS) that will be treated in one of the participating Sarcoma Reference Centers according to one of the treatment approaches defined in the 5 cohorts.

Criteria

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

Contacts and Locations