Clinical Trials /

Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

NCT02106312

Description:

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.

Related Conditions:
  • Myxoid Liposarcoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
  • Official Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

Clinical Trial IDs

  • ORG STUDY ID: N10DMY
  • SECONDARY ID: 2588
  • NCT ID: NCT02106312

Conditions

  • Myxoid Liposarcoma of Soft Tissue

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.

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.
    

Trial Arms

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

    Eligibility 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 -
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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.
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:The Netherlands Cancer Institute

    Trial Keywords

    • Radiotherapy
    • Myxoid liposarcoma
    • Soft tissue sarcoma

    Last Updated