A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in aSTS in a Real World Setting in Greece (beYOND-STS)

November 26, 2020 updated by: Genesis Pharma S.A.

A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and the Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in Advanced Soft Tissue Sarcomas in a Real World Setting in Greece. The 'beYOND-STS' Study

This non-interventional study aims primarily at assessing the clinical effectiveness and the impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it represents an attempt towards gaining experience on the routine use of trabectedin in daily clinical practice in a representative sample of Greek subjects with aSTS.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs

Description

Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

  • Adult outpatients (18 years and older) of either gender;
  • Patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs;
  • Patients for whom the decision to prescribe therapy with trabectedin (Yondelis®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study;
  • Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
  • Patients must have signed an informed consent document;
  • Patients must be able to read, understand and complete the study specific questionnaires.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation in this study:

  • Patients who have received more than one cycle of trabectedin at the time of enrolment into the study;
  • Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
  • Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with trabectedin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement.
Time Frame: 6 months post-treatment onset
The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement
6 months post-treatment onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genesis Pharma S.A.

Investigators

  • Study Director: Kiki Karvounis, GenesisPharma Medical Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

August 6, 2019

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GEN-TRA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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