A Multicenter, Prospective, oBservational Study to assEss... | NCT02618122

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Aug 6, 2019Actual

First Submitted Date

Nov 25, 2015

First Submission Date that Met QC Criteria

Nov 26, 2015

First Posted Date

Dec 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2020

Last Update Posted Date

Nov 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Outcomes Module

Primary Outcomes

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.	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample