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

NCT ID NCT04383119

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • A.O.U.San Luigi Gonzaga

    RECRUITING

    Orbassano, Torino, 10043, Italy

    Contact Email: •••••@•••••

  • ASL Città di Torino (Dipartimento di Oncologia)

    RECRUITING

    Torino, 10153, Italy

    Contact Email: •••••@•••••

    Contact

    Contact

  • Azienda Ospedaliera S. Orsola-Malpighi

    RECRUITING

    Bologna, BO, 40138, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Centro di Riferimento Oncologico di Aviano

    NOT_YET_RECRUITING

    Aviano, PD, 33081, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Fondazione IRCCS INT Milano

    NOT_YET_RECRUITING

    Milan, 20133, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • H.San Martino di Genova

    RECRUITING

    Genova, Italy

    Contact Email: •••••@•••••

  • IRCCS Fondazione Piemonte per l'Oncologia

    RECRUITING

    Candiolo, Torino, 10060, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • IRCCS Istituto nazionale Tumori "Fondazione G.Pascale"

    RECRUITING

    Naples, Italy

    Contact Email: •••••@•••••

  • Irccs Istituto Oncologico Veneto (Iov)

    RECRUITING

    Padova, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, MI, 20089, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, Italy

    Contact Email: •••••@•••••

  • Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

    RECRUITING

    Bologna, 40136, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Istituto Regina Elena - IFO

    RECRUITING

    Rome, 00100, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

    RECRUITING

    Meldola, FC, Italy

    Contact Email: •••••@•••••

    Contact

  • Nuovo Ospedale di Prato

    RECRUITING

    Prato, Firenze, 59100, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Ospedale Giaccone

    RECRUITING

    Palermo, Italy

    Contact Email: •••••@•••••

    Contact

  • Policlinico Universitario Campus Biomedico

    RECRUITING

    Roma, RM, 00128, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact