TrIPReSarc: Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

Sponsor

Technische Universität München (Other)

Overall Status

Unknown status

CT.gov ID

NCT02509234

Collaborator

(none)

Enrollment

40.9

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma Recurrent Rhabdomyosarcoma	Drug: Combined chemotherapy with trabectedin followed by irinotecan

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Trabectedin and Irinotecan in Pediatric Refractory Sarcomas

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Jul 1, 2017

Outcome Measures

Primary Outcome Measures

Toxicity during therapy [As long as patient is undergoing therapy/ 6 months]
WHO toxicity grading

Secondary Outcome Measures

Quality of life [12 months]
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.
Assessment of therapeutic effect [12 months]
Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
Assessment of time to treatment failure [12 months]
Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.

Other Outcome Measures

Overall survival in comparison to matched controls. [12 months]
Comparison of overall survival in a matched pair analysis.
Differences in response rate comparing response rate in Ewing Sarcoma to response rate in Soft Tissue Sarcoma [12 months]
Statistical comparison of response rate according to RECIST in Ewing Sarcoma vs. Soft Tissue Sarcoma
Event free survival in comparison to matched controls. [12 months]
Comparison of event free survival in a matched pair analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Technische Universität München

Investigators

Study Chair: Stefan Burdach, Prof., Kinderklinik München Schwabing - Klinik und Poliklinik für Kinder- und Jugendmedizin, Klinikum Schwabing, Städtisches Klinikum München GmbH und Klinikum Rechts der Isar (AöR) der Technischen Universität München