OncoMatch/Clinical Trials/NCT04383119
Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Is NCT04383119 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trabectedin and Gemcitabine for leiomyosarcoma of ovary.
Treatment: Trabectedin · Gemcitabine · No Intervention: Observational Cohort — Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline
Patients who received at least on previous systemic treatment with anthracycline-based chemotherapy.
Cannot have received: trabectedin
Prior treatment with Trabectedin
Cannot have received: gemcitabine
Prior treatment with ... Gemcitabine
Lab requirements
Blood counts
Adequate bone marrow function
Kidney function
Adequate renal function; Creatinin Clearance <30 ml/min or Creatinine >1,5 mg/dL excluded; Patients undergoing renal dialysis excluded
Liver function
Adequate liver function
Cardiac function
Left Ventricular Ejection Fraction ≥ 50% and/or above lower institutional limit of normality.
Adequate bone marrow, liver and renal function; Left Ventricular Ejection Fraction ≥ 50% and/or above lower institutional limit of normality.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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