Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS) (E-TRAB)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03022448 |
Recruitment Status :
Completed
First Posted : January 16, 2017
Last Update Posted : April 4, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Actual Enrollment : | 72 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 : | February 2, 2017 |
Actual Primary Completion Date : | December 31, 2021 |
Actual Study Completion Date : | December 31, 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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
Austria | |
Klinikum Klagenfurt am Wörthersee | |
Klagenfurt, Austria | |
Medizinische Universität Wien | |
Wien, Austria | |
Germany | |
HELIOS Klinikum Bad Saarow | |
Bad Saarow, Germany | |
HELIOS Klinikum Berlin Buch | |
Berlin, Germany | |
Klinikum Spandau | |
Berlin, Germany | |
Universitätsklinikum Carl Gustav Carus der TU Dresden | |
Dresden, Germany | |
Universitätsklinikum Heidelberg | |
Heidelberg, Germany | |
University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit | |
Mannheim, Germany | |
Klinikum Nürnberg Nord | |
Nürnberg, Germany | |
Universitätsklinikum Ulm | |
Ulm, Germany | |
Switzerland | |
Universitätsspital Bern | |
Bern, Switzerland | |
Kantonsspital St. Gallen | |
Saint Gallen, Switzerland |
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 |
Other Study ID Numbers: |
E-Trab |
First Posted: | January 16, 2017 Key Record Dates |
Last Update Posted: | April 4, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
soft tissue sarcomas (STS) trabectedin metastatic STS patients overall survival |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |