Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma (NCT04383119) | Clinical Trial Compass
RecruitingPhase 2
Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Italy100 participantsStarted 2021-10-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Measurable or evaluable disease with RECIST 1.1 criteria.
✓. Evidence of progression according RECIST 1.1 during the 6 months before study entry.
✓. Age ≥18 years
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Exclusion criteria
✕. 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
What they're measuring
1
Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine in second line
✕. 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
✕. Metastatic brain or meningeal tumors
✕. Active viral hepatitis
✕. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus
✕. Patients with any severe and/or uncontrolled medical conditions