NCT03022448

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 4, 2022

Status Verified

April 1, 2022

Enrollment Period

4.9 years

First QC Date

January 13, 2017

Last Update Submit

April 1, 2022

Conditions

Advanced Soft-tissue SarcomaMetastatic Soft-tissue Sarcoma

Keywords

soft tissue sarcomas (STS)trabectedinmetastatic STS patientsoverall survival

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

No InterventionOTHER

This is a NIS. No intervention.

Treatment Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Written informed consent
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

Location

Medizinische Universität Wien

Vienna, Austria

Location

HELIOS Klinikum Bad Saarow

Bad Saarow, Germany

Location

HELIOS Klinikum Berlin Buch

Berlin, Germany

Location

Klinikum Spandau

Berlin, Germany

Location

Universitätsklinikum Carl Gustav Carus der TU Dresden

Dresden, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit

Mannheim, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Universitätsspital Bern

Bern, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Bernd Kasper, Prof.

    University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 16, 2017

Study Start

February 2, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)CH(2)DE(8)