Geriatric Assessmen of Elderly "Unsuited" Patients Receiv... | NCT03022448

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2017Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jan 13, 2017

First Submission Date that Met QC Criteria

Jan 13, 2017

First Posted Date

Jan 16, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2022

Last Update Posted Date

Apr 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	This is a NIS. No intervention.	Treatment Group

Measure	Description	Time Frame
Overall survival	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.	12 month after LPFV

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Klagenfurt am Wörthersee		Klagenfurt			Austria
Medizinische Universität Wien

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms