New hope for rare cancer: trabectedin vs gemcitabine in leiomyosarcoma trial

NCT ID NCT04383119

Recruiting now Disease control Sponsor: Italian Sarcoma Group Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial compares the chemotherapy drugs trabectedin and gemcitabine in 100 people with advanced leiomyosarcoma that has worsened after initial treatment. The study aims to see which drug better delays cancer progression. It also includes an observational group for those who cannot or choose not to be randomized.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Trabectedin and gemcitabine (chemotherapy drugs)
What this could lead to: If trabectedin works better than gemcitabine, it could become a new standard second-line treatment for advanced leiomyosarcoma.
What could go wrong: This is a phase II trial with only 100 participants, so results may not be definitive. Both drugs have side effects, and the study may not show a clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

leiomyosarcoma ovary leiomyosarcoma sarcoma soft tissue sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LEIOMYOSARCOMA OF OVARY SOFT TISSUE SARCOMA

Contacts and locations

Locations

A.O.U.San Luigi Gonzaga
RECRUITING

Orbassano, Torino, 10043, Italy
ASL Città di Torino (Dipartimento di Oncologia)
RECRUITING

Torino, 10153, Italy
Azienda Ospedaliera S. Orsola-Malpighi
RECRUITING

Bologna, BO, 40138, Italy
Centro di Riferimento Oncologico di Aviano
NOT_YET_RECRUITING

Aviano, PD, 33081, Italy
Fondazione IRCCS INT Milano
NOT_YET_RECRUITING

Milan, 20133, Italy
H.San Martino di Genova
RECRUITING

Genova, Italy
IRCCS Fondazione Piemonte per l'Oncologia
RECRUITING

Candiolo, Torino, 10060, Italy
IRCCS Istituto nazionale Tumori "Fondazione G.Pascale"
RECRUITING

Naples, Italy
Irccs Istituto Oncologico Veneto (Iov)
RECRUITING

Padova, Italy
Istituto Clinico Humanitas
RECRUITING

Rozzano, MI, 20089, Italy
Istituto Europeo di Oncologia
RECRUITING

Milan, Italy
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
RECRUITING

Bologna, 40136, Italy
Istituto Regina Elena - IFO
RECRUITING

Rome, 00100, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
RECRUITING

Meldola, FC, Italy
Nuovo Ospedale di Prato
RECRUITING

Prato, Firenze, 59100, Italy
Ospedale Giaccone
RECRUITING

Palermo, Italy
Policlinico Universitario Campus Biomedico
RECRUITING

Roma, RM, 00128, Italy

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