Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients
Reason given: The study was terminated prematurely due to slow recruitment after inclusion of 7 patients (of initially planned 100 patients).
Key facts
- Where
- Bad Saarow, Berlin, Frankfurt am Main, Göttingen, Greifswald, Leipzig, Mainz, Münster, and Tübingen, GermanySee the 9 sites
Where in Germany
- HELIOS Klinikum Bad SaarowBad Saarow, GermanyNo longer taking part
- Helios Klinikum Berlin BuchBerlin, GermanyNo longer taking part
- Frankfurt UniversitätsklinikumFrankfurt am Main, GermanyNo longer taking part
- Universitätsmedizin GöttingenGöttingen, GermanyNo longer taking part
- Universitätsmedizin GreifswaldGreifswald, GermanyNo longer taking part
- Uniklinikum LeipzigLeipzig, GermanyNo longer taking part
- Universitätsmedizin MainzMainz, GermanyNo longer taking part
- Westfälische Wilhelms-Universität MünsterMünster, GermanyNo longer taking part
- Universitätsklinikum TübingenTübingen, GermanyNo longer taking part
Trial details
- Who runs it
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Trial code
- NCT06050434
- Record updated
- 1 December 2025
- Original description
Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. The prospective study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.Read full original descriptionShow less
PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study
Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. The prospective study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.
Inclusion: Enrolled participant of the GISAR registry and their sub-studies; Patient with histologically confirmed soft tissue sarcomas; Pretreatment with Trabectedin, termination of this therapy regardless of reason; Planned rechallenge or started rechallenge with Trabectedin in any line of therapy within 2 weeks before inclusion; Interval between last Trabectedin treatment and Trabectedin rechallenge at least 3 months.
Exclusion: Age ≤ 18 years; Not able to understand all implications of study participation; No written informed consent.