Metastatic or locally advanced leiomyosarcoma
Conditions
Brief summary
Compare the growth modulation index (GMI) in patients treated with Trabectedin or Gemcitabine for locally relapsed/metastatic leiomyosarcoma pretreated with anthracycline-based chemotherapy. GMI is the ratio of time to progression with the nth line (TTPn) of therapy to the TTPn−1 with the n-1th line. GMI >1.33 is considered as a sign of activity in phase II trials (Penel Ann Oncology). GMI will be calculated as the ratio between TTPTrabectedin/Gemcitabine and TTPfirst line.
Detailed description
To evaluate Overall Response Rate (ORR) determined by RECIST, version 1.1 in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine., To evaluate overall survival (OS) in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine, To evaluate Progression Free Survival (PFS) and Progression Free Survival Rate (PFSR) at 6 months in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine, To evaluate duration of response (DOR) per RECIST, version 1.1 in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine., To evaluate GMI2 calculated as the ratio of TTPthird line and TTPsecond line in the subset of patients who crossed over after progression to second line, To evaluate the safety and tolerability of Trabectedin compared to Gemcitabine, Exploratory objectives will be to identify gene mutations that may be associated to response/resistance to the treatment and to clinical outcomes parameters. Patients will be also exploratory evaluated according to the following subgroups: - age (<65 vs. ≥65) - sex (males vs. females) - site of disease (uterine LMS and non-uterine LMS) - ECOG performance status (0 vs. ≥1). -First line anthracycline based chemotherapy (single agent vs. combined chemotherapy)
Interventions
DRUGYondelis 0.25 mg powder for concentrate for solution for infusion
Sponsors
Italian Sarcoma Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the growth modulation index (GMI) in patients treated with Trabectedin or Gemcitabine for locally relapsed/metastatic leiomyosarcoma pretreated with anthracycline-based chemotherapy. GMI is the ratio of time to progression with the nth line (TTPn) of therapy to the TTPn−1 with the n-1th line. GMI >1.33 is considered as a sign of activity in phase II trials (Penel Ann Oncology). GMI will be calculated as the ratio between TTPTrabectedin/Gemcitabine and TTPfirst line. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Overall Response Rate (ORR) determined by RECIST, version 1.1 in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine., To evaluate overall survival (OS) in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine, To evaluate Progression Free Survival (PFS) and Progression Free Survival Rate (PFSR) at 6 months in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine, To evaluate duration of response (DOR) per RECIST, version 1.1 in patients with advanced leiomyosarcoma treated with Trabectedin compared to patients treated with Gemcitabine., To evaluate GMI2 calculated as the ratio of TTPthird line and TTPsecond line in the subset of patients who crossed over after progression to second line, To evaluate the safety and tolerability of Trabectedin compared to Gemcitabine, Exploratory objectives will be to identify | — |
Countries
Italy
Outcome results
None listed