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DOse REduction of preoperatieve radiotherapyin MYxoid liposarcoma.
(Dosis verlaging van de preoperatieve bestraling van myxoid liposarcomen).



- candidate number8627
- NTR NumberNTR2588
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-nov-2010
- Secondary IDsN10DMY 
- Public TitleDOse REduction of preoperatieve radiotherapyin MYxoid liposarcoma.
(Dosis verlaging van de preoperatieve bestraling van myxoid liposarcomen).
- Scientific TitleDOse REduction of preoperatieve radiotherapyin MYxoid liposarcoma.
- ACRONYMDoremy
- hypothesisThe induction of necrosis after reduced RT dose.
- Healt Condition(s) or Problem(s) studiedRadiotherapy, Myxoid liposarcoma, Soft tissue sarcoma
- Inclusion criteria1. Age >18 years;
2. By biopsy proven myxoid sarcoma;
3. Performance score ECOG 0-2.
- Exclusion criteria1. Prior radiotherapy to target area;
2. Anticoagulant medication of any kind; especially Ascal (and derivates), coumarines, all heparin and heparin-like formulations;
3. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jul-2012
- Target number of participants10
- InterventionsTo study whether a dose reduction of preoperative radiotherapy in MLS from 50Gy to 36Gy is equally effective in inducing extensive necrosis (thus maintaining comparable clinicopathological responses).
- Primary outcomeThe dose reduction will be regarded as a success if at least 90% of thus treated patients show at least 90% necrosis in the definitive resection specimen.
- Secondary outcomeThe aim is to provide a stopping rule for inefficacy of the new dose.
- Timepoints1. Start inclusion 01-Jan-2011;
2. Finish 01-Jul-2012.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R.L.M. Haas
- CONTACT for SCIENTIFIC QUERIESDr. R.L.M. Haas
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- PublicationsN/A
- Brief summaryTo study whether a dose reduction of preoperative radiotherapy in MLS from 50Gy to 36Gy is equally effective in inducing extensive necrosis (thus maintaining comparable clinicopathological responses).
- Main changes (audit trail)
- RECORD5-nov-2010 - 8-feb-2011


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