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

NCT ID NCT04383119

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with histologically documented diagnosis of leiomyosarcoma 2. Patients with diagnosis of unresectable or metastatic leiomyosarcoma 3. Patients who received at least on previous systemic treatment with anthracycline-based chemotherapy. 4. Patients suitable to receive gemcitabine or trabectedin therapy. 5. Measurable or evaluable disease with RECIST 1.1 criteria. 6. Evidence of progression according RECIST 1.1 during the 6 months before study entry. 7. Age ≥18 years 8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 9. All previous anticancer treatments must have completed ≥ 3 weeks prior to first dose of study drug. 10. The patient has resolution of adverse events, with the exception of alopecia, and of all clinically significant toxic effects of prior loco-regional therapy, surgery, radiotherapy or systemic anticancer therapy to ≤ Grade 1, by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 11. Adequate bone marrow, liver and renal function 12. Left Ventricular Ejection Fraction ≥ 50% and/or above lower institutional limit of normality. 13. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. 14. No history of arterial and/or venous thromboembolic event within the previous 12 months. 15. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent prior to any study specific procedure. The subject may also provide an optional consent for the biological/translational sub-study associated. Exclusion Criteria: 1. Prior treatment with Trabectedin and/or Gemcitabine 2. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs 3. History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse. 4. Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies 5. Metastatic brain or meningeal tumors 6. Active viral hepatitis 7. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus 8. Patients with any severe and/or uncontrolled medical conditions 9. Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment 10. Active clinically serious infections 11. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus 12. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, 13. Major surgery within 4 weeks prior to study entry 14. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors 15. Concomitant use of known strong or moderate CYP3A inducers 16. Patients undergoing renal dialysis or with Creatinin Clearance \<30 ml/min or Creatinine \>1,5 mg/dL 17. Pregnant or breast feeding patients 18. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.