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

NCT02618122 | Completed

• 1 other identifier: NIS-GEN-TRA-001
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genesis Pharma S.A.: lead

Study Sites (1)

Thessaloniki

Thessaloniki, Greece

Location

Study Officials

• Kiki Karvounis

  GenesisPharma Medical Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2015
• Primary Completion: June 30, 2019
• Study Completion: August 6, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

GR (1)