Clinical trial NCT03022448: Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
Official title: Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Soft-tissue Sarcoma
Metastatic Soft-tissue Sarcoma
Keywords: soft tissue sarcomas (STS)
trabectedin
metastatic STS patients
overall survival
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with advanced and/or metastatic STS (≥ 60 years including a maximum of 1/6 of "unsuited" patients younger than 60 years)

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 12 month after LPFV
Secondary outcomes:
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin Buch
city: Berlin
country: Germany
facility: Klinikum Spandau
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus der TU Dresden
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Mannheim
country: Germany
facility: University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Bern
country: Switzerland
facility: Universitätsspital Bern
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
name: Bernd Kasper, Prof.
role: PRINCIPAL_INVESTIGATOR
References: