Clinical trial · Observational
Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
- 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)
Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany. Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
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 |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Yondelis
- description
- The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.
- interventionNames
- Drug: trabectedin
Primary outcomes (2)
- measure
- 3 months progression free survival (PFS) rate
- timeFrame
- 3 months after start of therapy
- description
- Number of patients without PD or death 3 months after start of therapy
- measure
- 6 months progression free survival (PFS) rate
- timeFrame
- 6 months after start of therapy
- description
- Number of patients without PD or death 6 months after start of therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must comply with all of the following criteria in order to be enrolled into the study: * Histologically diagnosed advanced STS * Female or male aged 18 years or above * Signed written informed consent * Suitable to undergo treatment with trabectedin according to SmPC * Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents Exclusion Criteria: * Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.
References
Publications (0)
Data not yet available