An observational study in Myxoid Liposarcoma, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by The Netherlands Cancer Institute · Observational
To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)
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.
40 studies on the registry are indexed under Liposarcoma, Myxoid; 12 are open to participants now.
Browse Liposarcoma, Myxoid studies →The Netherlands Cancer Institute is the lead sponsor of 231 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MLS patients managed by surgery only
Procedure: Surgery
MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery
Procedure: Surgery · Radiation: Preoperative RT 36Gy
MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery
Procedure: Surgery · Radiation: Preoperative RT 50Gy
MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent)
Procedure: Surgery · Radiation: Postoperative RT 50-66Gy
MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent)
Radiation: RT 36Gy
Surgery
Preoperative radiotherapy to 36Gy (equivalent)
Preoperative radiotherapy to 50Gy (equivalent)
Postoperative radiotherapy to 50-66Gy (equivalent)
Definitive radiotherapy to 36Gy (equivalent)
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-up
Wound complications
Any wound complication requiring intervention
Time frame: From surgery to 6 months of follow-up
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-up
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-up
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-up
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Jan 2031, 120 months after the start.
How these figures are worked out, and which studies are left out of them.
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