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Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas (DOREMY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02106312
Recruitment Status : Unknown
Verified June 2020 by The Netherlands Cancer Institute.
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2014
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myxoid Liposarcoma of Soft Tissue Radiation: dose reduction of preoperative radiotherapy in MLS Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
Actual Study Start Date : December 15, 2010
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106312


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, MA 02215
Harvard Cancer Center
Boston, Massachusetts, United States, MA 02215
Denmark
University Hospital Aarhus
Aarhus, Denmark, 8000
Netherlands
The Netherlands Cancer Institute
Amsterdam, Noord Holland, Netherlands, 1066CX
Academisch Medisch centrum
Amsterdam, Netherlands, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333ZA
Maastro Clinic
Maastricht, Netherlands, 6229 ET
Radboud umc
NIjmegen, Netherlands, 6225GA
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Oslo University Hospital
Oslo, Norway, N-310
United Kingdom
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Rick Haas, MD,PhD The Netherlands Cancer Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02106312    
Other Study ID Numbers: N10DMY
2588 ( Other Identifier: Nederlands trial register )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
Radiotherapy
Myxoid liposarcoma
Soft tissue sarcoma
Additional relevant MeSH terms:
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Liposarcoma
Liposarcoma, Myxoid
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma