Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas (DOREMY)
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Myxoid Liposarcoma of Soft Tissue||Radiation: dose reduction of preoperative radiotherapy in MLS||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 -
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
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, MA 02215|
|Harvard Cancer Center|
|Boston, Massachusetts, United States, MA 02215|
|University Hospital Aarhus|
|Aarhus, Denmark, 8000|
|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|
|Maastricht, Netherlands, 6229 ET|
|NIjmegen, Netherlands, 6225GA|
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Oslo University Hospital|
|Oslo, Norway, N-310|
|Royal Marsden Hospital|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||Rick Haas, MD,PhD||The Netherlands Cancer Institute|
|Responsible Party:||The Netherlands Cancer Institute|
|Other Study ID Numbers:||
2588 ( Other Identifier: Nederlands trial register )
|First Posted:||April 8, 2014 Key Record Dates|
|Last Update Posted:||August 4, 2021|
|Last Verified:||June 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Soft tissue sarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type