Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS) (E-TRAB)
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ClinicalTrials.gov Identifier: NCT03022448 |
Recruitment Status :
Recruiting
First Posted : January 16, 2017
Last Update Posted : October 23, 2018
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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.
Condition or disease | Intervention/treatment |
---|---|
Advanced Soft-tissue Sarcoma Metastatic Soft-tissue Sarcoma | Other: No Intervention |
Study Type : | Observational |
Estimated Enrollment : | 110 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS) |
Actual Study Start Date : | January 2017 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | January 2021 |

Group/Cohort | Intervention/treatment |
---|---|
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.
|
Other: No Intervention
This is a NIS. No intervention. |
- Overall survival [ Time Frame: 12 month after LPFV ]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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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022448
Contact: Martin Puttrich | +49 (0) 351 25933 193 | Martin.Puttrich@gwtonline.de |
Austria | |
Klinikum Klagenfurt am Wörthersee | Recruiting |
Klagenfurt, Austria | |
Contact: Wolfgang Eisterer, Prof. Dr. | |
Medizinische Universität Wien | Recruiting |
Wien, Austria | |
Contact: Thomas Brodowicz, Prof. Dr. | |
Germany | |
HELIOS Klinikum Bad Saarow | Recruiting |
Bad Saarow, Germany | |
Contact: Daniel Pink, Dr. | |
HELIOS Klinikum Berlin Buch | Recruiting |
Berlin, Germany | |
Contact: Peter Reichardt, PD | |
Klinikum Spandau | Recruiting |
Berlin, Germany | |
Contact: Annegret Kunitz, Dr. | |
Universitätsklinikum Carl Gustav Carus der TU Dresden | Recruiting |
Dresden, Germany | |
Contact: Stephan Richter, Dr. | |
Universitätsklinikum Heidelberg | Recruiting |
Heidelberg, Germany | |
Contact: Gerlinde Egerer, Prof. Dr. | |
University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit | Recruiting |
Mannheim, Germany | |
Contact: Bernd Kasper, Prof. +49 621 383 2580 bernd.kasper@umm.de | |
Klinikum Nürnberg Nord | Recruiting |
Nürnberg, Germany | |
Contact: Marinela Augustin, Dr. | |
Universitätsklinikum Ulm | Recruiting |
Ulm, Germany | |
Contact: Verena Gaidzik, Dr. | |
Switzerland | |
Universitätsspital Bern | Recruiting |
Bern, Switzerland | |
Contact: Attila Kollar, Dr. med. | |
Kantonsspital St. Gallen | Recruiting |
Saint Gallen, Switzerland | |
Contact: Christian Rothermundt, Dr. |
Principal Investigator: | Bernd Kasper, Prof. | University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit |
Responsible Party: | GWT-TUD GmbH |
ClinicalTrials.gov Identifier: | NCT03022448 History of Changes |
Other Study ID Numbers: |
E-Trab |
First Posted: | January 16, 2017 Key Record Dates |
Last Update Posted: | October 23, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by GWT-TUD GmbH:
soft tissue sarcomas (STS) trabectedin metastatic STS patients overall survival |
Additional relevant MeSH terms:
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Trabectedin |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |