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Completed

NCT Number: NCT03022448

Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)

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.

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Key information

Conditions

Advanced Soft-tissue Sarcoma Metastatic Soft-tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is a NIS. No intervention.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Registry information

Acronym: E-TRAB

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 16, 2017
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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