Condition: Leiomyosarcoma of Ovary · Soft Tissue Sarcoma · Sponsor: Italian Sarcoma Group
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.
This description comes directly from the study's public registry record.
Bruno Vincenzi, Prof/MD · 003906-22541 · b.vincenzi@unicampus.it
Emanuela Marchesi, PhD · 003905101459 · emanuela.marchesi@italiansarconmagroup.org
Always discuss trial participation with your own doctor first.
| Azienda Ospedaliera S. Orsola-Malpighi | Bologna, BO, Italy | Recruiting |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST | Meldola, FC, Italy | Recruiting |
| Nuovo Ospedale di Prato | Prato, Firenze, Italy | Recruiting |
| Istituto Clinico Humanitas | Rozzano, MI, Italy | Recruiting |
| Centro di Riferimento Oncologico di Aviano | Aviano, PD, Italy | Not Yet Recruiting |
| Policlinico Universitario Campus Biomedico | Roma, RM, Italy | Recruiting |
| IRCCS Fondazione Piemonte per l'Oncologia | Candiolo, Torino, Italy | Recruiting |
| A.O.U.San Luigi Gonzaga | Orbassano, Torino, Italy | Recruiting |
| Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors | Bologna, Italy | Recruiting |
| H.San Martino di Genova | Genova, Italy | Recruiting |
| Fondazione IRCCS INT Milano | Milan, Italy | Not Yet Recruiting |
| Istituto Europeo di Oncologia | Milan, Italy | Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04383119