International Prospective Registry on Local Treatment Approaches in MLS
ConditionMyxoid Liposarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
About this trial
To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prior radiotherapy to the target area
Pregnancy
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgery
Procedure/SurgerySurgery
Preoperative RT 36Gy
RadiationPreoperative radiotherapy to 36Gy (equivalent)
Preoperative RT 50Gy
RadiationPreoperative radiotherapy to 50Gy (equivalent)
Postoperative RT 50-66Gy
RadiationPostoperative radiotherapy to 50-66Gy (equivalent)
RT 36Gy
RadiationDefinitive radiotherapy to 36Gy (equivalent)
Treatment groups
300 Participants
are divided into 5 treatment groupsGroup A: Cohort A1 intervention
Group B: Cohort B2 interventions
Group C: Cohort C2 interventions
Group D: Cohort D2 interventions
Group E: Cohort E1 intervention
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
Wound complications
Any wound complication requiring intervention
Time frame
From surgery to 6 months of follow-up2
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-upOther outcomes
1
Patient-Reported Outcome Measures (PROMs)
PRO-CTCAE Item Library; relevant questions from the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)
Time frame
From baseline visit to the end of 5 years of follow-up2
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;
Time frame
From baseline visit to the end of 5 years of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Netherlands Cancer Institute
Lead sponsor
Radboud University Medical Center
Collaborator
Maastro Clinic, The Netherlands
Collaborator
University Medical Center Groningen
Collaborator
Leiden University Medical Center
Collaborator
Vienna General Hospital
Collaborator
M.D. Anderson Cancer Center
Collaborator
University Hospital, Antwerp
Collaborator
Universitetssykehus
Collaborator
Haukeland University Hospital
Collaborator
Universitäts-Frauenklinik Graz
Collaborator
University Hospital Heidelberg
Collaborator
Mayo Clinic
Collaborator
Aarhus University Hospital
Collaborator
National Cancer Center, Japan
Collaborator
Princess Margaret Hospital, Canada
Collaborator
MOUNT SINAI HOSPITAL
Collaborator
University of Sydney
Collaborator
Institute for Cancer Research and treatment
Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborator
Institut Curie
Collaborator
Australia and New Zealand Sarcoma Association
Collaborator
Source ClinicalTrials.gov