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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-08-06

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Soft Tissue Sarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kiki Karvounis

Role: STUDY_DIRECTOR

GenesisPharma Medical Department

Locations

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Thessaloniki

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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NIS-GEN-TRA-001

Identifier Type: -

Identifier Source: org_study_id