Clinical trial · Observational
Trabectedin and Irinotecan for Refractory Pediatric Sarcomas
Trabectedin and Irinotecan in Pediatric Refractory Sarcomas
NCT02509234CI-TRIAL-00018658TrIPReSarcunknownClinicalTrials.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 the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Childhood Soft Tissue Sarcoma | Childhood Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Recurrent Ewing Sarcoma | Ewing Sarcoma | CURATED_BROADER | 0.78 |
| Recurrent Rhabdomyosarcoma | Rhabdomyosarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined chemotherapy with trabectedin followed by irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity during therapy
- timeFrame
- As long as patient is undergoing therapy/ 6 months
- description
- WHO toxicity grading
Secondary outcomes (3)
- measure
- Quality of life
- timeFrame
- 12 months
- description
- Assessment of quality of life at the day before starting the next cycle and at months 3, 6, 9 and 12 after start of treatment, using adapted Karnofsky Score.
- measure
- Assessment of therapeutic effect
- timeFrame
- 12 months
- description
- Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention) * existing matched control in existing study databases * have started of treatment within three months of last progress Key Exclusion Criteria: * Patients newly diagnosed or in first relapse.
References
Publications (0)
Data not yet available
No reference posted for this study.