International Prospective Registry on Local Treatment Approaches in MLS
NCT ID: NCT04699292
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2021-01-18
2031-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
MLS patients managed by surgery only
Surgery
Surgery
Cohort B
MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery
Surgery
Surgery
Preoperative RT 36Gy
Preoperative radiotherapy to 36Gy (equivalent)
Cohort C
MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery
Surgery
Surgery
Preoperative RT 50Gy
Preoperative radiotherapy to 50Gy (equivalent)
Cohort D
MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent)
Surgery
Surgery
Postoperative RT 50-66Gy
Postoperative radiotherapy to 50-66Gy (equivalent)
Cohort E
MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent)
RT 36Gy
Definitive radiotherapy to 36Gy (equivalent)
Interventions
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Surgery
Surgery
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Maastro Clinic, The Netherlands
OTHER
University Medical Center Groningen
OTHER
Leiden University Medical Center
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
ANZSA (Australia and New Zealand Sarcoma Association)
UNKNOWN
The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Rick Haas, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Locations
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The Netherlands Cancer Institute
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Rick Haas, MD/PhD
Role: primary
Jules Lansu, MD/PhD
Role: backup
Other Identifiers
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IRBd20-354
Identifier Type: OTHER
Identifier Source: secondary_id
M20DMY
Identifier Type: -
Identifier Source: org_study_id
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