Can a simple test predict who will respond to this sarcoma drug?
NCT ID NCT04008238
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to find biological markers that can predict whether the drug trabectedin will work in patients with certain types of soft-tissue sarcoma. Researchers will collect tumor biopsies and blood samples from 29 participants before and during treatment. The goal is to use advanced testing to identify which patients are most likely to benefit, potentially leading to more personalized treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trabectedin
- What this could lead to
- If successful, this could help doctors identify which sarcoma patients are most likely to benefit from trabectedin, making treatment more personalized.
- What could go wrong
- This is a small, early-stage study focused on finding biomarkers, not on proving treatment effectiveness. The results may not apply to all sarcoma types or lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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29 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years, 2. Histology: undifferentiated pleomorphic sarcomas, epithelioid sarcomas, solitary fibrous tumors, hemangioendothelioma, desmoplastic round cell tumors, synovial sarcomas or other non-leiomyosarcoma/non-liposarcoma softtissue sarcoma. As per the Frech NCI recommendation, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de Référence en Pathologie des Sarcomes des tissus mous et des Viscères), 3. Locally advanced/unresectable and/or metastatic disease, 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 1), 5. Measurable disease according to RECIST v1.1, 6. Indication of trabectedin according to market authorization, 7. At least one target lesion that can be biopsied for research, 8. Women of childbearing potential must have a negative serum pregnancy test before study entry, 9. Patient with a social security in compliance with the French law, 10. Voluntary signed and dated written informed consent prior to any study specific procedure, 11. Women must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of trabectedin. Men must agree to use a medically acceptable method of contraception throughout the treatment period and for 5 months after discontinuation of trabectedin. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>=1 year. Exclusion Criteria: 1. Previous treatment with trabectedin, 2. Known hypersensitivity to any of its components, 3. Patients with an active serious or uncontrolled infection upon investigator judgement, 4. Radiological evidence of symptomatic or progressive brain metastases, 5. Abnormal coagulation contraindicating biopsy, 6. Any medical and/or biological contra-indication to treatment by trabectedin as per market authorization specification (as per investigator judgement), 7. Patients unable to receive corticotherapy, 8. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer, 9. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV), 10. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, 11. Individuals deprived of liberty or placed under guardianship, 12. Pregnant or breast feeding women, 13. Previous enrolment in the present study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institut Bergonie
Bordeaux, 33076, France
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