International Prospective Registry on Local Treatment Approaches in MLS
2 other identifiers
observational
300
1 country
1
Brief Summary
To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 7, 2021
CompletedStudy Start
First participant enrolled
January 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
August 30, 2022
August 1, 2022
10 years
January 6, 2021
August 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Wound complications
From surgery to 6 months of follow-up
Late toxicity
From 3 months after surgery to the end of at least 5 years of follow-up
Other Outcomes (2)
Patient-Reported Outcome Measures (PROMs)
From baseline visit to the end of 5 years of follow-up
Health-Related Quality of Life (HRQoL)
From baseline visit to the end of 5 years of follow-up
Study Arms (5)
Cohort A
MLS patients managed by surgery only
Cohort B
MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery
Cohort C
MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery
Cohort D
MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent)
Cohort E
MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent)
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Prior radiotherapy to the target area
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Cancer Institutelead
- Radboud University Medical Centercollaborator
- Maastro Clinic, The Netherlandscollaborator
- University Medical Center Groningencollaborator
- Leiden University Medical Centercollaborator
- Vienna General Hospitalcollaborator
- M.D. Anderson Cancer Centercollaborator
- University Hospital, Antwerpcollaborator
- Universitetssykehuscollaborator
- Haukeland University Hospitalcollaborator
- Universitäts-Frauenklinik Grazcollaborator
- University Hospital Heidelbergcollaborator
- Mayo Cliniccollaborator
- Aarhus University Hospitalcollaborator
- National Cancer Center, Japancollaborator
- Princess Margaret Hospital, Canadacollaborator
- MOUNT SINAI HOSPITALcollaborator
- University of Sydneycollaborator
- Institute for Cancer Research and treatmentcollaborator
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milanocollaborator
- Institut Curiecollaborator
- Australia and New Zealand Sarcoma Associationcollaborator
Study Sites (1)
The Netherlands Cancer Institute
Amsterdam, 1066CX, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rick Haas, MD/PhD
The Netherlands Cancer Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2021
First Posted
January 7, 2021
Study Start
January 18, 2021
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
January 1, 2031
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share