International Prospective Registry on Local Treatment Approaches in MLS

NCT ID: NCT04699292

Last Updated: 2022-08-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2031-01-31

Brief Summary

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To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)

Detailed Description

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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.

Conditions

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Myxoid Liposarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

MLS patients managed by surgery only

Surgery

Intervention Type PROCEDURE

Surgery

Cohort B

MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery

Surgery

Intervention Type PROCEDURE

Surgery

Preoperative RT 36Gy

Intervention Type RADIATION

Preoperative radiotherapy to 36Gy (equivalent)

Cohort C

MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery

Surgery

Intervention Type PROCEDURE

Surgery

Preoperative RT 50Gy

Intervention Type RADIATION

Preoperative radiotherapy to 50Gy (equivalent)

Cohort D

MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent)

Surgery

Intervention Type PROCEDURE

Surgery

Postoperative RT 50-66Gy

Intervention Type RADIATION

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

Intervention Type RADIATION

Definitive radiotherapy to 36Gy (equivalent)

Interventions

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Surgery

Surgery

Intervention Type PROCEDURE

Preoperative RT 36Gy

Preoperative radiotherapy to 36Gy (equivalent)

Intervention Type RADIATION

Preoperative RT 50Gy

Preoperative radiotherapy to 50Gy (equivalent)

Intervention Type RADIATION

Postoperative RT 50-66Gy

Postoperative radiotherapy to 50-66Gy (equivalent)

Intervention Type RADIATION

RT 36Gy

Definitive radiotherapy to 36Gy (equivalent)

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role collaborator

Maastro Clinic, The Netherlands

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Vienna General Hospital

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Universitetssykehus

UNKNOWN

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Universitäts-Frauenklinik Graz

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

National Cancer Center, Japan

OTHER_GOV

Sponsor Role collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

MOUNT SINAI HOSPITAL

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role collaborator

Institute for Cancer Research and treatment

UNKNOWN

Sponsor Role collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role collaborator

Institut Curie

OTHER

Sponsor Role collaborator

ANZSA (Australia and New Zealand Sarcoma Association)

UNKNOWN

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Rick Haas, MD/PhD

Role: CONTACT

+31 20 512 9111

Jules Lansu, MD/PhD

Role: CONTACT

+31 20 512 9111

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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