This trial is active, not recruiting.

Conditions recurrent childhood soft tissue sarcoma, recurrent ewing sarcoma, recurrent rhabdomyosarcoma
Treatment combined chemotherapy with trabectedin followed by irinotecan
Sponsor Technische Universität München
Start date February 2014
End date July 2016
Trial size 30 participants
Trial identifier NCT02509234, TrI.PReSarc V150429


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective

Primary Outcomes

Toxicity during therapy
time frame: As long as patient is undergoing therapy/ 6 months

Secondary Outcomes

Quality of life
time frame: 12 months
Assessment of therapeutic effect
time frame: 12 months
Assessment of time to treatment failure
time frame: 12 months

Eligibility Criteria

Male or female participants from 10 years up to 40 years old.

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.

Additional Information

Official title Trabectedin and Irinotecan in Pediatric Refractory Sarcomas
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Technische Universität München.