Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorItalian Sarcoma Group
About this trial
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 criteria
Qualifiers
Patients with histologically documented diagnosis of leiomyosarcoma
Patients with diagnosis of unresectable or metastatic leiomyosarcoma
Patients who received at least on previous systemic treatment with anthracycline-based chemotherapy.
Patients suitable to receive gemcitabine or trabectedin therapy.
Disqualifiers
Prior treatment with Trabectedin and/or Gemcitabine
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
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.
Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies
Trial design
Treatments tested in this trial
- Trabectedin
- Gemcitabine
- No Intervention: Observational Cohort
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Italian Sarcoma Group
Lead sponsor
PharmaMar
Collaborator
Source ClinicalTrials.gov