Clinical trial · Interventional
An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)
NCT00796120CI-TRIAL-00020158completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trabectedin
- description
- Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
- interventionNames
- Drug: Trabectedin
- type
- ACTIVE_COMPARATOR
- label
- Doxorubicin plus Ifosfamide
- description
- Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
- interventionNames
- Drug: Doxorubicin
- Drug: Ifosfamide
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of translocation-related sarcomas (TRS) including the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid/round cell liposarcoma (MRCL) and synovial sarcoma * Participants must have unresectable locally advanced or metastatic progressive disease prior to enrolment * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2 * Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within normal limits according to institutional standards, as shown by echocardiography or scintigraphy multiple-gated acquisition scan \[MUGA\] * Measurable disease as defined by the radiological (computed tomography \[CT\] scan and magnetic resonance imaging \[MRI\]) Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) guidelines Exclusion Criteria: * Known hypersensitivity to any components of the intravenous formulation of trabectedin or the comparators * Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is available * Brain metastases and/or leptomeningeal metastases, even if treated * Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods * History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more
References
Publications (1)
- DERIVEDBlay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. doi: 10.1016/j.ejca.2014.01.012. Epub 2014 Feb 7. PMID 24512981