- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022448
Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS) (E-TRAB)
The aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide.
Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Klagenfurt, Austria
- Klinikum Klagenfurt am Wörthersee
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Wien, Austria
- Medizinische Universitat Wien
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Bad Saarow, Germany
- HELIOS Klinikum Bad Saarow
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Berlin, Germany
- Helios Klinikum Berlin Buch
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Berlin, Germany
- Klinikum Spandau
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Dresden, Germany
- Universitätsklinikum Carl Gustav Carus der TU Dresden
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Heidelberg, Germany
- UniversitatsKlinikum Heidelberg
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Mannheim, Germany
- University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
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Nürnberg, Germany
- Klinikum Nurnberg Nord
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Ulm, Germany
- Universitatsklinikum Ulm
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Bern, Switzerland
- Universitätsspital Bern
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Saint Gallen, Switzerland
- Kantonsspital St. Gallen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Written informed consent
- Age of ≥ 60 years at study inclusion with a limited number of "unsuited" patients younger than 60 years
- Histologically proven advanced and/or metastatic STS, intermediate/high grade
- Presence of measurable disease according to RECIST 1.1. (optional, according to local clinical practice)
- Patients indicated for 1st line treatment with trabectedin according to local SmPC
- ECOG Performance Status 0, 1 or 2
- bone marrow function according to local SmPC
- hepatic function according to local SmPC
- Ability to understand and follow study-related instructions
Exclusion Criteria:
- Histologically proven advanced and/or metastatic STS of the following tumor types:
- Embryonal rhabdomyosarcoma
- Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
- Osteosarcoma (excluding extraskeletal osteosarcoma)
- Ewing tumors/primitive neuroectodermal tumor
- Gastrointestinal stromal tumors
- Dermatofibrosarcoma protuberans
- Use of any investigational agent within 28 days prior to treatment start
- Exclusion periods from other studies or simultaneous participation in other clinical studies
- Contraindications according to the local SmPC of Yondelis® (see Appendix A)
- Subject is in custody by order of an authority or a court of law
- Previous assignment to the E-Trab study (An individual subject may only be included once in the study)
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Treatment Group
Trabectedin will be used according to the local SmPC.
Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
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This is a NIS.
No intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 12 month after LPFV
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Overall survival for each patient will be followed until the end of the study that is defined by 12 months after inclusion of the last patient.
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12 month after LPFV
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bernd Kasper, Prof., University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-Trab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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