Clinical trial · Observational
Retrospective Study of Trabectedin in Soft Tissue Sarcomas
Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)
NCT02793050CI-TRIAL-00038551TrObscompletedClinicalTrials.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)
This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting. A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug.
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, Soft Tissue | 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
- Trabectedin
- description
- Trabectedin give according the market authorization for advanced soft tissue sarcoma
- interventionNames
- Drug: Trabectedin
Primary outcomes (1)
- measure
- Post-trabectedin received treatment
- timeFrame
- Through treatment completion, an average of 24 month
- description
- Number of chemotherapy lines received after trabectedin given according to the approved indication
Secondary outcomes (5)
- measure
- Tumor response
- timeFrame
- after 6 months from trabectedin start date
- description
- Percent of patients with non progressing disease at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who received trabectedin according to the approved indication in the period January 2010 December 2015 Exclusion Criteria: * Trabectedin started before January 2010 and after December 2015 * Participation into clinical trials with trabectedin * Clinical chart missing, empty, or not retrievable.
References
Publications (20)
- BACKGROUNDStiller CA, Trama A, Brewster DH, Verne J, Bouchardy C, Navarro C, Chirlaque MD, Marcos-Gragera R, Visser O, Serraino D, Weiderpass E, Dei Tos AP, Ascoli V; RARECARE Working Group. Descriptive epidemiology of Kaposi sarcoma in Europe. Report from the RARECARE project. Cancer Epidemiol. 2014 Dec;38(6):670-8. doi: 10.1016/j.canep.2014.09.009. Epub 2014 Oct 22. PMID 25454979
- BACKGROUNDESMO/European Sarcoma Network Working Group. Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii102-12. doi: 10.1093/annonc/mdu254. No abstract available. PMID 25210080
- BACKGROUNDJudson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litiere S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5. PMID 24618336
- BACKGROUNDSleijfer S, Ouali M, van Glabbeke M, Krarup-Hansen A, Rodenhuis S, Le Cesne A, Hogendoorn PC, Verweij J, Blay JY. Prognostic and predictive factors for outcome to first-line ifosfamide-containing chemotherapy for adult patients with advanced soft tissue sarcomas: an exploratory, retrospective analysis on large series from the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG). Eur J Cancer. 2010 Jan;46(1):72-83. doi: 10.1016/j.ejca.2009.09.022. PMID 19853437
- BACKGROUNDItaliano A, Mathoulin-Pelissier S, Cesne AL, Terrier P, Bonvalot S, Collin F, Michels JJ, Blay JY, Coindre JM, Bui B. Trends in survival for patients with metastatic soft-tissue sarcoma. Cancer. 2011 Mar 1;117(5):1049-54. doi: 10.1002/cncr.25538. Epub 2010 Oct 13.