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Soft Tissue SarcomaPhase 3TSARNCT02672527

Trial Comparing Trabectedin to the Best Supportive Care in Patients With Sarcoma

A Phase 3 study testing Trabectedin and Dexamethasone in people with Soft Tissue Sarcoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in soft tissue sarcoma remain to be assessed. For an antineoplastic drug toxicity is moderate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Trabectedin and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteFrance
Study dates
22 Jan 2015to 14 Jul 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent understood, agreed and signed
  • Tolerance of the central venous line that will be used for Trabectedin infusions.
  • 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),
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  • 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.
  • Histological samples available for centralised histopathological diagnosis and the appropriate genetic diagnosis.
  • 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.
  • Measurable disease as per RECIST (Response Evaluation Criteria In Solid Tumors), and confirmed based on objective data within 14 days prior to study inclusion.
  • 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.
  • ECOG (Eastern Cooperative Oncology Group) Performance score: 0 or 1.
  • Normal cardiac function as assessed by cardiac ultrasound examination or by MUltiple Gated Acquisition scan (MUGA scan).
  • 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.
  • Patient having reached the majority age at the time they sign the informed consent.
  • Life expectancy of at least 3 months at study entry.
  • Patient covered by the health insurance system.
  • All women of childbearing potential must have a negative serum pregnancy test within 14 days prior to study inclusion.

Who cannot join

  • Hypersensitivity, history of allergic reaction to trabectedin
  • 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).
  • History of allergic reaction or known hypersensitivity to contrast agents (except if the patient's tumour can be evaluated using MRI without contrast agents).
  • Severe concomitant disease (such as pulmonary fibrosis, interstitial pneumonitis, renal insufficiency, liver failure, cerebrovascular disease, malignant disease requiring blood transfusions, or uncontrolled diabetes).
  • Clinically significant abnormalities of the electrocardiogram test, or one of the following clinically significant cardiac diseases :
  • Congestive cardiac insufficiency,
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  • Active coronary disease,
  • Arrhythmia poorly controlled by medicinal products only,
  • Myocardial infarction within one year prior to study entry.
  • Surgery under general anaesthesia within 28 days prior to study entry, exploratory surgery (thoracotomy or laparotomy) within 28 days prior to study entry,.
  • 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.
  • Radiotherapy within 21 days prior to study entry.
  • History of graft transplantation or stem cell transplantation.
  • Adverse reaction to a previous treatment, other than alopecia, long-lasting, and of grade ≥ 2 severity according to CTCAE (v. 4.0) criteria.
  • Intercurrent infection requiring a systemic antimicrobial treatment (e.g., associated with fever ≥ 38° C),
  • Patients HIV positive and/or viral anti-therapy and/or hepatitis B and/or C. Systematic serology to check the status is not necessary.
  • Brain metastasis, either symptomatic or requiring a treatment.
  • 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).
  • Psychiatric disorders disturbing the informed consent process.
  • 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.
  • Other investigational treatment within 28 days prior to study entry.
  • Prior treatment with trabectedin.
  • Any clinical conditions not compatible with an adequate study conduct, according to investigator's judgement.
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy Cancer Campus Grand Paris

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

Official title: A Randomized Phase III Trial Comparing Trabectedin (Yondelis®) to the Best Supportive Care in Patients With Advanced Soft Tissue Sarcoma

As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in soft tissue sarcoma remain to be assessed.

For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival data for patients with advanced or metastatic STS are of poor prognosis despite improvement of results this last years. For example, median overall survival increased from 12,3 months (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006).

Considering the latest results with and without Trabectedin, the investigators may consider that comparing Trabectedin with best supportive care is ethically acceptable as long as patients consent to enter the trial.

Being tested
Trabectedin, Dexamethasone
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02672527
Study groupRoleWhat they receive
TRAExperimentalAt Day 1 (D1), premedication with dexamethasone (20 mg) and a 5-HT3 receptor antagonist anti-emetic agent will be intravenously administered 30 minutes prior to trabectedin administration. Trabectedin will be administered through a central venous catheter at a starting dose of 1.5 mg/m² over 24 hours, diluted in at least 500 mL of normal saline solution or of glucose 5% injectable solution. Each treatment cycle will last 21 days. Treatment duration: the treatment might be pursued until disease progression according to RECIST 1.1, or patient refusal, or toxicities. In case of disease progression, the further treatments will be based on investigator's judgement.
Receives: Drug: Trabectedin; Drug: Dexamethasone
BSCNo interventionTreatment: Patients will receive the best supportive care (BSC) in order to alleviate their symptoms and improve their Quality of Life (QoL). Antineoplastic agents (including surgery, radiotherapy, thermotherapy, chemotherapy, immunotherapy, hormonal treatment or antibodies-based treatments) are prohibited. Treatment duration: the treatment might be pursued until disease progression according to RECIST 1.1, or patient refusal. In case of disease progression, a treatment with trabectedin will be proposed (cross-over). In case of patient refusal, the further treatments will be based on investigator's judgement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Measured: Assessed every three weeks after randomization then every six weeks until progression or death of any cause whichever came first up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2016 (estimated)
  2. Study start22 Jan 2015
  3. Primary completion14 Jul 2018
  4. Study completion14 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02672527
Sponsor's protocol ID
2014-003176-23
Other IDs
2014/2154, 2014
Acronym
TSAR
Status last verified
Aug 2026
First submitted
6 May 2015
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No

Publications

  • Le Cesne A, Blay JY, Cupissol D, Italiano A, Delcambre C, Penel N, Isambert N, Chevreau C, Bompas E, Bertucci F, Chaigneau L, Piperno-Neumann S, Salas S, Rios M, Guillemet C, Bay JO, Ray-Coquard I, Haddag L, Bonastre J, Kapso R, Fraslin A, Bouvet N, Mir O, Foulon S. A randomized phase III trial comparing trabectedin to best supportive care in patients with pre-treated soft tissue sarcoma: T-SAR, a French Sarcoma Group trial. Ann Oncol. 2021 Aug;32(8):1034-1044. doi: 10.1016/j.annonc.2021.04.014. Epub 2021 Apr 29.

    PubMed 33932507

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trabectedin and Dexamethasone in people with Soft Tissue Sarcoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Assessed every three weeks after randomization then every six weeks until progression or death of any cause whichever came first up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02672527, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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