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Study identifier: NCT04383119 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

Condition: Leiomyosarcoma of Ovary · Soft Tissue Sarcoma  ·  Sponsor: Italian Sarcoma Group

PhasePhase 2
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Bruno Vincenzi, Prof/MD  ·  003906-22541  ·  b.vincenzi@unicampus.it

Emanuela Marchesi, PhD  ·  003905101459  ·  emanuela.marchesi@italiansarconmagroup.org

Always discuss trial participation with your own doctor first.

Locations (17)

Azienda Ospedaliera S. Orsola-MalpighiBologna, BO, ItalyRecruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRSTMeldola, FC, ItalyRecruiting
Nuovo Ospedale di PratoPrato, Firenze, ItalyRecruiting
Istituto Clinico HumanitasRozzano, MI, ItalyRecruiting
Centro di Riferimento Oncologico di AvianoAviano, PD, ItalyNot Yet Recruiting
Policlinico Universitario Campus BiomedicoRoma, RM, ItalyRecruiting
IRCCS Fondazione Piemonte per l'OncologiaCandiolo, Torino, ItalyRecruiting
A.O.U.San Luigi GonzagaOrbassano, Torino, ItalyRecruiting
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal TumorsBologna, ItalyRecruiting
H.San Martino di GenovaGenova, ItalyRecruiting
Fondazione IRCCS INT MilanoMilan, ItalyNot Yet Recruiting
Istituto Europeo di OncologiaMilan, ItalyRecruiting

+ 5 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04383119