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| ID | Type | Description | Link |
|---|---|---|---|
| IRBd20-354 | Other Identifier | The Netherlands Cancer Institute |
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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
| Maastro Clinic, The Netherlands | OTHER |
| University Medical Center Groningen | OTHER |
| Leiden University Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | MLS patients managed by surgery only |
| |
| Cohort B | MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery |
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| Cohort C | MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery |
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| Cohort D | MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent) |
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| Cohort E | MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | Any wound complication requiring intervention | From surgery to 6 months of follow-up |
| Late toxicity | Any grade ≥2 late (radiation-induced) toxicity according to CTCAE v5.0 toxicity criteria |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Health-Related Quality of Life (HRQoL) |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rick Haas, MD/PhD | Contact | +31 20 512 9111 | r.haas@nki.nl | |
| Jules Lansu, MD/PhD | Contact | +31 20 512 9111 | j.lansu@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rick Haas, MD/PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Netherlands Cancer Institute | Recruiting | Amsterdam | 1066CX | Netherlands |
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| ID | Term |
|---|---|
| D018208 | Liposarcoma, Myxoid |
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Vienna General Hospital | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| University Hospital, Antwerp | OTHER |
| Universitetssykehus | UNKNOWN |
| Haukeland University Hospital | OTHER |
| Universitäts-Frauenklinik Graz | OTHER |
| University Hospital Heidelberg | OTHER |
| Mayo Clinic | OTHER |
| Aarhus University Hospital | OTHER |
| National Cancer Center, Japan | OTHER_GOV |
| Princess Margaret Hospital, Canada | OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
| University of Sydney | OTHER |
| Institute for Cancer Research and treatment | UNKNOWN |
| Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | OTHER |
| Institut Curie | OTHER |
| Australia and New Zealand Sarcoma Association | OTHER |
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| Preoperative RT 36Gy | Radiation | Preoperative radiotherapy to 36Gy (equivalent) |
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| Preoperative RT 50Gy | Radiation | Preoperative radiotherapy to 50Gy (equivalent) |
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| Postoperative RT 50-66Gy | Radiation | Postoperative radiotherapy to 50-66Gy (equivalent) |
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| RT 36Gy | Radiation | Definitive radiotherapy to 36Gy (equivalent) |
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| From 3 months after surgery to the end of at least 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;
| From baseline visit to the end of 5 years of follow-up |
| D009369 | Neoplasms |
| D012509 | Sarcoma |