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Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas (DOREMY)

Primary Purpose

Myxoid Liposarcoma of Soft Tissue

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dose reduction of preoperative radiotherapy in MLS
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myxoid Liposarcoma of Soft Tissue focused on measuring Radiotherapy, Myxoid liposarcoma, Soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Dana-Farber Cancer Institute
  • Harvard Cancer Center
  • University Hospital Aarhus
  • The Netherlands Cancer Institute
  • Academisch Medisch centrum
  • Universitair Medisch Centrum Groningen
  • Leids Universitair Medisch Centrum
  • Maastro Clinic
  • Radboud umc
  • Haukeland University Hospital
  • Oslo University Hospital
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiation

Arm Description

Dose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 6, 2014
Last Updated
August 3, 2021
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02106312
Brief Title
Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
Acronym
DOREMY
Official Title
Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2010 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myxoid Liposarcoma of Soft Tissue
Keywords
Radiotherapy, Myxoid liposarcoma, Soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiation
Arm Type
Other
Arm Description
Dose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY.
Intervention Type
Radiation
Intervention Name(s)
dose reduction of preoperative radiotherapy in MLS
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above or equal to 18 years 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). ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2 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. Written informed consent Exclusion Criteria: Prior radiotherapy to the target area. 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.) Pregnancy -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Haas, MD,PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
MA 02215
Country
United States
Facility Name
Harvard Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
MA 02215
Country
United States
Facility Name
University Hospital Aarhus
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
The Netherlands Cancer Institute
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Academisch Medisch centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
Maastro Clinic
City
Maastricht
ZIP/Postal Code
6229 ET
Country
Netherlands
Facility Name
Radboud umc
City
NIjmegen
ZIP/Postal Code
6225GA
Country
Netherlands
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-310
Country
Norway
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33180100
Citation
Lansu J, Bovee JVMG, Braam P, van Boven H, Flucke U, Bonenkamp JJ, Miah AB, Zaidi SH, Thway K, Bruland OS, Baldini EH, Jebsen NL, Scholten AN, van den Ende PLA, Krol ADG, Ubbels JF, van der Hage JA, van Werkhoven E, Klomp HM, van der Graaf WTA, van Coevorden F, Schrage Y, van Houdt WJ, Haas RL. Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2021 Jan 1;7(1):e205865. doi: 10.1001/jamaoncol.2020.5865. Epub 2021 Jan 21.
Results Reference
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Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

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