Myxoid Liposarcoma
Conditions
Brief summary
To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)
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.
Interventions
PROCEDURESurgery
Surgery
RADIATIONPreoperative RT 36Gy
Preoperative radiotherapy to 36Gy (equivalent)
RADIATIONPreoperative RT 50Gy
Preoperative radiotherapy to 50Gy (equivalent)
RADIATIONPostoperative RT 50-66Gy
Postoperative radiotherapy to 50-66Gy (equivalent)
RADIATIONRT 36Gy
Definitive radiotherapy to 36Gy (equivalent)
Sponsors
Radboud University Medical Center
Maastro Clinic, The Netherlands
University Medical Center Groningen
Leiden University Medical Center
Vienna General Hospital
M.D. Anderson Cancer Center
University Hospital, Antwerp
Universitetssykehus
Haukeland University Hospital
Universitäts-Frauenklinik Graz
University Hospital Heidelberg
Mayo Clinic
Aarhus University Hospital
National Cancer Center, Japan
Princess Margaret Hospital, Canada
MOUNT SINAI HOSPITAL
University of Sydney
Institute for Cancer Research and treatment
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Institut Curie
Australia and New Zealand Sarcoma Association
The Netherlands Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence free survival | From surgery to the end of at least 5 years of follow-up | Survival from surgery to local recurrence (event) or last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound complications | From surgery to 6 months of follow-up | Any wound complication requiring intervention |
| Late toxicity | From 3 months after surgery to the end of at least 5 years of follow-up | Any grade ≥2 late (radiation-induced) toxicity according to CTCAE v5.0 toxicity criteria |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcome Measures (PROMs) | From baseline visit to the end of 5 years of follow-up | PRO-CTCAE Item Library; relevant questions from the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) |
| Health-Related Quality of Life (HRQoL) | From baseline visit to the end of 5 years of follow-up | 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; |
Countries
Netherlands
Contacts
Primary ContactRick Haas, MD/PhD
Backup ContactJules Lansu, MD/PhD
Outcome results
None listed