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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02204111
Other study ID # YonLife-2014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date September 2017

Study information

Verified date November 2018
Source GWT-TUD GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 treatment.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intervention
Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes

Locations

Country Name City State
Germany Charité Berlin
Germany University Hospital Carl Gustav Carus, MK I Dresden Saxony
Germany Hannover Medical School Hannover
Germany University Hospital Koeln Koeln
Germany University Medical Centre Mannheim Mannheim
Germany University Hospital Muenster Muenster
Germany University Hospital Tuebingen Tuebingen

Sponsors (2)

Lead Sponsor Collaborator
GWT-TUD GmbH PharmaMar

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health related QoL, measured by total score of FACT-G assessed by the patient using standard questionnaire (FACT-G) via tablet-PC change to baseline at 9 weeks
Secondary Dimensions of QoL (scales of FACT-G) assessed by the patient using standard questionnaire (FACT-G) via tablet-PC baseline, 3, 6, 9, 21, 35 and 61 weeks
Secondary Anxiety and depression (HADS) assessed by the patient using standard questionnaire (HADS) via tablet-PC baseline, 9, 21, 35 and 61 weeks
Secondary Satisfaction with care (IN-PATSAT32) assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC baseline, 9, 21, 35 and 61 weeks
Secondary Anorexia and cachexia related impact on QoL (FAACT) assessed by the patient using standard questionnaire (FAACT) via tablet-PC baseline, 9, 21, 35 and 61 weeks
Secondary Intensity of pain and pain related interference (BPI) assessed by the patient using standard questionnaire (BPI) via tablet-PC baseline, 9, 21, 35 and 61 weeks
Secondary Severity of cancer-related symptoms (MDASI) assessed by the patient using standard questionnaire (MDASI) via tablet-PC baseline, 3, 6, 9, 21, 35 and 61 weeks
Secondary progression free survival baseline up to 61 weeks
Secondary Overall survival baseline up to 61 weeks
See also
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Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
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Terminated NCT03520959 - A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) Phase 3
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