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Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

Status: Recruiting
Phase: Phase 2
Diagnosis: Sarcoma
NCT ID: NCT02106312 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Elizabeth Baldini, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Thomas DeLaney, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Andrew Crocker, 617-525-8099, acrocker@lroc.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

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 -
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