Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas (DOREMY)

August 3, 2021 updated by: The Netherlands Cancer Institute
To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.
  • Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • University Hospital Aarhus
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Leiden, Netherlands, 2333ZA
        • Leids Universitair Medisch Centrum
      • Maastricht, Netherlands, 6229 ET
        • Maastro clinic
      • NIjmegen, Netherlands, 6225GA
        • Radboud UMC
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1066CX
        • The Netherlands Cancer Institute
  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
      • Oslo, Norway, N-310
        • Oslo University Hospital
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, MA 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, MA 02215
        • Harvard Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age above or equal to 18 years
  2. Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).
  3. ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
  4. Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
  5. Written informed consent

Exclusion Criteria:

  1. Prior radiotherapy to the target area.
  2. Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
  3. Pregnancy -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Radiation
Dose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY.
Radiation: dose reduction of preoperative radiotherapy in MLS
A: The primary sarcoma in case of non-metastatic disease for management is with curative intent (regime to be chosen=18 x 2 Gy) B: In case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 Gy in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study)
Time Frame: The percentage of pathological responses will be pathologically assessed on the resection specimen; this procedure will take on average 7-10 working days. After surgery, patients will be followed up to 10 years.
The percentage of pathological responses will be pathologically assessed on the resection specimen; this procedure will take on average 7-10 working days. After surgery, patients will be followed up to 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Rick Haas, MD,PhD, The Netherlands Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2010

Primary Completion (Anticipated)

December 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N10DMY
  • 2588 (Nederlands trial register)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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