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

GWT-TUD

Status: Completed

Conditions: Metastatic Soft-tissue Sarcoma; Advanced Soft-tissue Sarcoma

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03022448

E-Trab

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 1 patient group

Treatment Group

Description:

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.

Treatment:

Other: No Intervention