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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04699292
Other study ID # M20DMY
Secondary ID IRBd20-354
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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Active, not recruiting NCT00633165 - Brostallicin Clinical Trial for Myxoid Liposarcoma Phase 2
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Active, not recruiting NCT03816475 - Hypofractionated Radiotherapy in Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall (LIPO-MYX Trial) Phase 2