Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Met… (NCT02805725) | Clinical Trial Compass
CompletedPhase 1/2
Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide
France50 participantsStarted 2015-12
Plain-language summary
Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).
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 soft-tissue sarcoma histologically confirmed by central review
. Metastatic or unresectable locally advanced disease,
. Age ≥ 18 years,
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2,
. Life expectancy \> 3 months,
. Measurable disease according to RECIST v1.1 outside any previously irradiated field,
. For patients included in phase II study, progressive disease according to RECIST v1.1 criteria diagnosed on the basis of two CT scan or MRI obtained at an interval less than 6 months in the period of 12 months prior to inclusion and confirmed by central review,
. Previous use of Anthracyclines,
Exclusion criteria
. Previous treatment with Trabectedin,
. Currently active bacterial or fungus infection (\> grade 2 CTC \[CTCAE\] HIV1, HIV2, hepatitis B or hepatitis C infections,
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
Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP.
Timeframe: During the first cycle (28 days)
2
Phase I: Number of Patients Who Experienced Dose-Limiting Toxicities (DLTs)
Timeframe: During the first cycle (28 days)
3
Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1)
Timeframe: Phase II : 6 months after the start of treatment
. History of chronic alcohol use and/or cirrhosis,
. The following unstable cardiac conditions are not allowed:
. Patients unable to receive corticotherapy,
. Known central nervous system malignancy (CNS),
. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
. Participation to a study involving a medical or therapeutic intervention in the last 30 days,