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Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

NCT04383119 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Leiomyosarcoma of Ovary
  • Soft Tissue Sarcoma

Interventions

DRUG

Trabectedin

Trabectedin in monotherapy

DRUG

Gemcitabine

Gemcitabine, control arm

DRUG

No Intervention: Observational Cohort

Treatment according clinical practice

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Italian Sarcoma Group

    lead NETWORK

Principal Investigators

  • Bruno Vincenzi, Prof/MD · Campus Biomedico of Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383119 on ClinicalTrials.gov