Clinical trial
Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
Name
ET-D-023-13
Description
Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.
Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Trial arms
Trial start
2015-07-16
Estimated PCD
2020-12-31
Trial end
2020-12-31
Status
Completed
Treatment
trabectedin
The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.
Arms:
Yondelis
Other names:
Yondelis
Size
130
Primary endpoint
3 months progression free survival (PFS) rate
3 months after start of therapy
6 months progression free survival (PFS) rate
6 months after start of therapy
Eligibility criteria
Inclusion Criteria:
* Patients must comply with all of the following criteria in order to be enrolled into the study:
* Histologically diagnosed advanced STS
* Female or male aged 18 years or above
* Signed written informed consent
* Suitable to undergo treatment with trabectedin according to SmPC
* Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents
Exclusion Criteria:
* Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 130, 'type': 'ACTUAL'}}
Updated at
2023-06-22
1 organization
Organization
PharmaMar