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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine in second line
. 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
. 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