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Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas (DOREMY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by The Netherlands Cancer Institute
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT02106312
First received: March 6, 2014
Last updated: April 10, 2014
Last verified: November 2012
  Purpose

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 Intervention Phase
Myxoid Liposarcoma of Soft Tissue
Radiation: dose reduction of preoperative radiotherapy in MLS
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • The Pathological description of the percentage necrosis 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 necrosis 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106312

Contacts
Contact: Rick Haas, MD,Phd +31 20 5122135 r.haas@nki.nl
Contact: Astrid Scholten, MD,PhD +31205121714 a.scholten@nki.nl

Locations
Netherlands
The Netherlands Cancer Institute Recruiting
Amsterdam, Noord Holland, Netherlands, 1066CX
Principal Investigator: Elisabeth Pras, MD,PhD         
Principal Investigator: Piet LA van der Ende, MD,PhD         
Principal Investigator: Petra Braam, MD,PhD         
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
Principal Investigator: Rick Haas, MD,PhD The Netherlands Cancer Institute
  More Information

No publications provided

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02106312     History of Changes
Other Study ID Numbers: N10DMY, 2588
Study First Received: March 6, 2014
Last Updated: April 10, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
Radiotherapy
Myxoid liposarcoma
Soft tissue sarcoma

Additional relevant MeSH terms:
Liposarcoma
Liposarcoma, Myxoid
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma

ClinicalTrials.gov processed this record on November 23, 2014