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

Advanced Soft Tissue Sarcoma Clinical Trial

— beYOND-STS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618122
• Other study ID #: NIS-GEN-TRA-001
• Status: Completed
• Start date: December 2015
• Est. completion date: August 6, 2019

Study information

• Verified date: November 2020
• Source: Genesis Pharma S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 6, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Soft Tissue Sarcoma
• Sarcoma

Locations

Country	Name	City	State
Greece	Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Genesis Pharma S.A.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients that are alive and progression-free (as per the RECIST v1.1 criteria) 6 months after treatment commencement.	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