Clinical Trial

Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

Study acronym: ISG-ARTICLE

Recruiting Phase 2

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.

Protocol Amendment History 10 amendments

This ClinicalTrials.gov record has been amended 10 times since 2020-05-06; most recent amendment 2026-03-24.

Status change: Active, Not Recruiting → Recruiting 2023-09-12

Status change: Not Yet Recruiting → Active, Not Recruiting 2021-10-29

Trial Details

NCT Number	NCT04383119
Lead Sponsor	Italian Sarcoma Group Collaborators: PharmaMar
Conditions	Leiomyosarcoma of Ovary, Soft Tissue Sarcoma
Enrollment	100 participants
Start Date	2021-10-29
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-25