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NCT Number: NCT04699292

International Prospective Registry on Local Treatment Approaches in MLS

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

Recruiting

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Key information

Conditions

Myxoid Liposarcoma Liposarcoma Liposarcoma, Myxoid Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

Location status: Recruiting

Location contact

Jules Lansu, MD/PhD

CONTACT

Rick Haas, MD/PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

Surgery

Preoperative RT 36Gy

Radiation

Preoperative radiotherapy to 36Gy (equivalent)

Preoperative RT 50Gy

Radiation

Preoperative radiotherapy to 50Gy (equivalent)

Postoperative RT 50-66Gy

Radiation

Postoperative radiotherapy to 50-66Gy (equivalent)

RT 36Gy

Radiation

Definitive radiotherapy to 36Gy (equivalent)

Primary outcomes

  1. Local recurrence free survival

    Time frame: 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 outcomes

  1. Wound complications

    Time frame: From surgery to 6 months of follow-up

    Any wound complication requiring intervention

  2. Late toxicity

    Time frame: 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 outcomes

  1. Patient-Reported Outcome Measures (PROMs)

    Time frame: 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)

  2. Health-Related Quality of Life (HRQoL)

    Time frame: 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;

Study contacts

Contact information is provided by the study sponsor or research team.

Jules Lansu, MD/PhD

CONTACT

[email protected]

+31 20 512 9111

Rick Haas, MD/PhD

CONTACT

[email protected]

+31 20 512 9111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Aarhus University Hospital
  • Australia and New Zealand Sarcoma Association
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • Haukeland University Hospital
  • Institut Curie
  • Institute for Cancer Research and treatment
  • Leiden University Medical Center
  • M.D. Anderson Cancer Center
  • MOUNT SINAI HOSPITAL
  • Maastro Clinic, The Netherlands
  • Mayo Clinic
  • National Cancer Center, Japan
  • Princess Margaret Hospital, Canada
  • Radboud University Medical Center
  • Universitetssykehus
  • University Hospital Heidelberg
  • University Hospital, Antwerp
  • University Medical Center Groningen
  • University of Sydney
  • Universitäts-Frauenklinik Graz
  • Vienna General Hospital

Registry information

Official study title

International Prospective Registry on Local Treatment Approaches in Myxoid Liposarcomas

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Jan 7, 2021
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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