Status:
COMPLETED
Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
Lead Sponsor:
GWT-TUD GmbH
Collaborating Sponsors:
PharmaMar
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of the study is to compare quality of life (QoL) between patients suffering from soft tissue sarcoma, receiving a multidimensional intervention with those receiving standard trea...
Eligibility Criteria
Inclusion
- Diagnosis of advanced or metastatic soft tissue sarcoma
- Treatment with trabectedin in an in-label prescription
- Age at least 18 years (inclusive) at the first visit
- Patients with a life expectancy of at least 6 months
- The informed consent form must be signed before any study specific tests or procedures are done
- Confirmation of the subject's health insurance coverage prior to the first visit
- Ability to understand and follow study-related instructions
Exclusion
- ECOG PS \>2
- Estimated life expectancy of less than 6 months
- Patients with STS not receiving trabectedin
- Contraindications according to the local SmPC of Yondelis®
- Subject is in custody by order of an authority or a court of law
- Exclusion periods from other studies or simultaneous participation in other clinical studies
- Previous assignment to treatment during this study
- Close affiliation with the investigator (e.g. a close relative) or persons working at the study site
- Subject is an employee of GWT-TUD GmbH or Pharma Mar S.A.
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT02204111
Start Date
September 1 2014
End Date
September 1 2017
Last Update
November 8 2018
Active Locations (7)
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1
University Hospital Carl Gustav Carus, MK I
Dresden, Saxony, Germany, 01307
2
Charité
Berlin, Germany, 13353
3
University Hospital Koeln
Cologne, Germany, 50937
4
Hannover Medical School
Hanover, Germany, 30625