International Prospective Registry on Local Treatment Approaches in MLS

International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas

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

Study Overview

• Status: Recruiting
• Conditions: Myxoid Liposarcoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Rick Haas, MD/PhD; Phone Number: +31 20 512 9111; Email: r.haas@nki.nl
• Study Contact Backup: Name: Jules Lansu, MD/PhD; Phone Number: +31 20 512 9111; Email: j.lansu@nki.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Recruiting
    • The Netherlands Cancer Institute
    • Contact: Rick Haas, MD/PhD
    • Contact: Jules Lansu, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome Measures (PROMs)	PRO-CTCAE Item Library; relevant questions from the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)	From baseline visit to the end of 5 years of follow-up
Health-Related Quality of Life (HRQoL)	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;	From baseline visit to the end of 5 years of follow-up

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: M.D. Anderson Cancer Center; Mayo Clinic; Radboud University Medical Center; Aarhus University Hospital; University Medical Center Groningen; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Haukeland University Hospital; University Hospital Heidelberg; University Hospital, Antwerp; University of Sydney; MOUNT SINAI HOSPITAL; Leiden University Medical Center; Princess Margaret Hospital, Canada; Institut Curie; National Cancer Center, Japan; Maastro Clinic, The Netherlands; Vienna General Hospital; Universitetssykehus; Universitäts-Frauenklinik Graz; Institute for Cancer Research and treatment; ANZSA (Australia and New Zealand Sarcoma Association)
• Investigators: Principal Investigator: Rick Haas, MD/PhD, The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2021
• Primary Completion (ANTICIPATED): January 1, 2031
• Study Completion (ANTICIPATED): January 1, 2031

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Adipose Tissue; Liposarcoma; Liposarcoma, Myxoid
• Other Study ID Numbers: M20DMY; IRBd20-354 (OTHER: The Netherlands Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No