International Prospective Registry on Local Treatment Approaches in MLS

Myxoid Liposarcoma Clinical Trial

Official title:

International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699292
• Other study ID #: M20DMY
• Secondary ID: IRBd20-354
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: January 2031

Study information

• Verified date: August 2022
• Source: The Netherlands Cancer Institute
• Contact: Rick Haas, MD/PhD
• Phone: +31 20 512 9111
• Email: r.haas[@]nki.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2031
• Est. primary completion date: January 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liposarcoma
• Liposarcoma, Myxoid
• Myxoid Liposarcoma

Intervention

Procedure:
• Surgery
Surgery

Radiation:
• Preoperative RT 36Gy
Preoperative radiotherapy to 36Gy (equivalent)
• Preoperative RT 50Gy
Preoperative radiotherapy to 50Gy (equivalent)
• Postoperative RT 50-66Gy
Postoperative radiotherapy to 50-66Gy (equivalent)
• RT 36Gy
Definitive radiotherapy to 36Gy (equivalent)

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam

Sponsors (22)

Lead Sponsor

Collaborator

The Netherlands Cancer Institute

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Wound complications	Any wound complication requiring intervention	From surgery to 6 months of follow-up
Secondary	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