Can a Marine-Derived drug slow advanced soft tissue sarcoma?

NCT ID NCT02672527

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This phase III trial compares the chemotherapy drug trabectedin (Yondelis) with best supportive care in people with advanced soft tissue sarcoma, a rare cancer of the connective tissues. The goal is to see if trabectedin can delay tumor growth and improve outcomes compared to supportive care alone. Participants receive either trabectedin infusions (with dexamethasone to reduce side effects) or standard supportive care. The study focuses on how long patients live without their cancer progressing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trabectedin (Yondelis), a chemotherapy drug, given alongside dexamethasone
What this could lead to
If trabectedin proves better than supportive care alone, it could become a standard treatment option to slow tumor growth and extend time without progression in advanced soft tissue sarcoma.
What could go wrong
This is a phase III trial, but results may not show a clear benefit over supportive care. Trabectedin can cause side effects like liver toxicity, nausea, and fatigue, which may affect quality of life.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

103 people

The number who actually took part.

Started

Jan 2015

Finished

Jul 2018

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Informed consent understood, agreed and signed 2. Tolerance of the central venous line that will be used for Trabectedin infusions. 3. Pathologically confirmed diagnosis of STS at the investigator centre level (and confirmed by Rrepps Network), except the following cases : * Low grade fibromyxoid sarcoma (LGFMS), * Giant Cells Fibroblastoma, * Dermatofibrosarcoma protuberances (DFSP), * Angiomatoid fibrous histiocytoma, * Alveolar Rhabdomyosarcoma and Embryonal Rhabdomyosarcoma, * Mesenchymal and Non-Mesenchymal Chondrosarcoma, * Extraskeletal Ewing Sarcoma / Primitive Neuroectodermal Tumour (PNET), * Desmoplastic small round-cell tumour (DSRCT ), * Gastro-Intestinal Stromal Tumour (GIST), * Endometrial Stroma Sarcoma, * Osteosarcoma. 4. Histological samples available for centralised histopathological diagnosis and the appropriate genetic diagnosis. 5. Patient who already received no more than 3 previous therapy lines. Therefore, trabectedin might be administered as a 2nd, 3rd or 4th therapy line in case of metastatic STS. 6. Measurable disease as per RECIST (Response Evaluation Criteria In Solid Tumors), and confirmed based on objective data within 14 days prior to study inclusion. 7. Disease progression according to RECIST 1.1 confirmed by imaging evaluation within 14 days prior to study inclusion comparatively to imaging within the previous 6 months. 8. ECOG (Eastern Cooperative Oncology Group) Performance score: 0 or 1. 9. Normal cardiac function as assessed by cardiac ultrasound examination or by MUltiple Gated Acquisition scan (MUGA scan). 10. Biological laboratory parameters meeting the following criteria within 14 days prior to study inclusion: * neutrophil leucocytes ≥ 1500 /μL, * haemoglobin ≥ 9,0 g/100 mL, * platelet count 100 x 103 /μL * AST (aspartate aminotransferase) ≤ 2.5 times the investigator local laboratory upper normal limit (UNL), * ALT (alanine aminotransferase) ≤ 2.5 times the investigator local laboratory UNL, * Alkaline phosphatases ≤ 2.5 UNL, * bilirubin ≤ UNL , * CPK ≤ 2.5 times the investigator laboratory UNL, * albumin ≥ 25 g/L * creatinine clearance measured or calculated (Cockcroft-Gault formula) ≥ 30 mL/min. 11. Patient having reached the majority age at the time they sign the informed consent. 12. Life expectancy of at least 3 months at study entry. 13. Patient covered by the health insurance system. 14. All women of childbearing potential must have a negative serum pregnancy test within 14 days prior to study inclusion. Exclusion Criteria: 1. Hypersensitivity, history of allergic reaction to trabectedin 2. History of allergic reaction or known hypersensitivity to dexamethasone or to anti-emetic agents belonging to the triptan family (i.e., 5-HT3 receptor antagonists). 3. History of allergic reaction or known hypersensitivity to contrast agents (except if the patient's tumour can be evaluated using MRI without contrast agents). 4. Severe concomitant disease (such as pulmonary fibrosis, interstitial pneumonitis, renal insufficiency, liver failure, cerebrovascular disease, malignant disease requiring blood transfusions, or uncontrolled diabetes). 5. Clinically significant abnormalities of the electrocardiogram test, or one of the following clinically significant cardiac diseases : * Congestive cardiac insufficiency, * Active coronary disease, * Arrhythmia poorly controlled by medicinal products only, * Myocardial infarction within one year prior to study entry. 6. Surgery under general anaesthesia within 28 days prior to study entry, exploratory surgery (thoracotomy or laparotomy) within 28 days prior to study entry,. 7. Treatment with one of the following anticancer agents prior to study entry : * hormonotherapy within 14 days prior to study entry, * other anticancer treatment (such as chemotherapy, targeted therapy, or biological advanced therapy) within 21 days prior to study entry. 8. Radiotherapy within 21 days prior to study entry. 9. History of graft transplantation or stem cell transplantation. 10. Adverse reaction to a previous treatment, other than alopecia, long-lasting, and of grade ≥ 2 severity according to CTCAE (v. 4.0) criteria. 11. Intercurrent infection requiring a systemic antimicrobial treatment (e.g., associated with fever ≥ 38° C), 12. Patients HIV positive and/or viral anti-therapy and/or hepatitis B and/or C. Systematic serology to check the status is not necessary. 13. Brain metastasis, either symptomatic or requiring a treatment. 14. History of another cancer within 5 years prior to study entry (except intra-epithelial neoplasm or basocellular cancer, if they are cured, e.g., thanks to surgical resection or radiotherapy). 15. Psychiatric disorders disturbing the informed consent process. 16. Pregnant or breast-feeding woman; man or woman not complying to contraceptive measures during the following time periods: * For the men, during the full study up to 5 months after the last study treatment administration; * For the women, femmes, during the full study up to 3 months after the last study treatment administration. 17. Other investigational treatment within 28 days prior to study entry. 18. Prior treatment with trabectedin. 19. Any clinical conditions not compatible with an adequate study conduct, according to investigator's judgement. 20. Patient under administrative or legal supervision, patient hospitalised without his/her consent or for other purposes than research, patient under guardianship or curators, or unable to express his/her consent.

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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

  • Gustave Roussy Cancer Campus Grand Paris

    Villejuif, Val de Marne, 94805, France

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