Leiomyosarcoma Clinical Trial
Official title:
A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)
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.
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 ;
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