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Spots Global Cancer Trial Database for Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.

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Trial Identification

Brief Title: Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.

Official Title: Phase 2 Randomized Trial of Trabectedin + Olaparib vs. Trabectedin in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.

Study ID: NCT03838744

Study Description

Brief Summary: Phase II study in patient with advanced Soft Tissue Sarcoma (STS) patients who have already received or are not suitable, for a doxorubicin-based treatment.

Detailed Description: Randomized, open-label, active-controlled, multicenter phase II clinical study. Patients will be randomly assigned in a 1:1 ratio to receive trabectedin 1.1 mg/m2 24-hour intravenous continuous infusion every 3 weeks with olaparib (per os) 150 mg twice a day versus trabectedin 1.5 mg/m2 intravenous 24-hour continuous infusion every 3 weeks until progression or unacceptable toxicity as second- or further-line treatment in a population of STS patients who have already received or are not suitable for a doxorubicin-based treatment.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Azienda Ospedaliero-Universitaria Di Bologna, Bologna, BO, Italy

I.R.S.T. di Meldola, Meldola, FC, Italy

Nuovo Ospedale di Prato, Prato, Firenze, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, MI, Italy

Istituto Europeo di Oncologia, Milano, MI, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone, Palermo, PA, Italy

Centro di Riferimento Oncologico di Aviano, Aviano, PD, Italy

Policlinico Universitario Campus Biomedico, Roma, RM, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo, Torino, Italy

Ospedale San Giovanni Bosco, Torino, TO, Italy

Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors, Bologna, , Italy

Irccs Istituto Oncologico Veneto (Iov), Padova, , Italy

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I, Roma, , Italy

Contact Details

Name: Giovanni Giovanni, MD

Affiliation: Fondazione del Piemonte IRCCS di Candiolo

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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