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Clinical Trial Summary

This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.


Clinical Trial Description

Standard arm: - Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm Experimental arm: - 3 cycles of neoadjuvant chemotherapy starting within 2 weeks following randomization: - High grade LPS: ADM (doxorubicin) 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m3 Q3 weeks. - LMS: ADM 75 mg/m2 + DTIC (dacarbazine) 1 g/m2 Q3 weeks - re-assessment of operability - curative-intent surgery within 3-6 weeks of last cycle of chemotherapy ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04031677
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact EORTC HQ
Phone +3227741611
Email 1809@eortc.org
Status Recruiting
Phase Phase 3
Start date January 20, 2021
Completion date April 21, 2028

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