RecruitingPhase 2NCT04383119

Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy


Sponsor

Italian Sarcoma Group

Enrollment

100 participants

Start Date

Oct 29, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy drugs — gemcitabine and trabectedin — for people with leiomyosarcoma (a type of soft tissue cancer) that has spread or cannot be removed surgically, and who have already received anthracycline-based chemotherapy. The goal is to find which second-line treatment works best. **You may be eligible if...** - You are 18 or older - You have confirmed leiomyosarcoma that is unresectable or metastatic - You have already received at least one prior chemotherapy regimen that included an anthracycline (like doxorubicin) - Your cancer has progressed within the past 6 months (confirmed by standard imaging) - Your overall health allows you to receive either gemcitabine or trabectedin - Your blood counts, heart, liver, and kidney function are adequate **You may NOT be eligible if...** - You have previously received trabectedin or gemcitabine - Your cancer has spread to the brain or surrounding membranes - You have HIV, active viral hepatitis - You have had a blood clot (deep vein thrombosis or pulmonary embolism) in the last year - You have severe bleeding history or active infections - You are pregnant or breastfeeding - You are on certain medications that affect how trabectedin is broken down in the body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrabectedin

Trabectedin in monotherapy

DRUGGemcitabine

Gemcitabine, control arm

DRUGNo Intervention: Observational Cohort

Treatment according clinical practice


Locations(17)

Azienda Ospedaliera S. Orsola-Malpighi

Bologna, BO, Italy

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

Meldola, FC, Italy

Nuovo Ospedale di Prato

Prato, Firenze, Italy

Istituto Clinico Humanitas

Rozzano, MI, Italy

Centro di Riferimento Oncologico di Aviano

Aviano, PD, Italy

Policlinico Universitario Campus Biomedico

Roma, RM, Italy

IRCCS Fondazione Piemonte per l'Oncologia

Candiolo, Torino, Italy

A.O.U.San Luigi Gonzaga

Orbassano, Torino, Italy

Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, Italy

H.San Martino di Genova

Genova, Italy

Fondazione IRCCS INT Milano

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

IRCCS Istituto nazionale Tumori "Fondazione G.Pascale"

Naples, Italy

Irccs Istituto Oncologico Veneto (Iov)

Padova, Italy

Ospedale Giaccone

Palermo, Italy

Istituto Regina Elena - IFO

Rome, Italy

ASL Città di Torino (Dipartimento di Oncologia)

Torino, Italy

View Full Details on ClinicalTrials.gov

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NCT04383119


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