Skip to main content
OpenTrials
Completed

NCT Number: NCT02793050

Retrospective Study of Trabectedin in Soft Tissue Sarcomas

This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting.

A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoma, Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, AL, Italy

Loading trial locations.

About this study

This is a national, multi-centre observational retrospective and prospective chart review study of treatment patterns and clinical outcomes in a subset of patients with Soft Tissue Sarcoma who received trabectedin as per licensed indication.

In the absence of availability of existing databases, a retrospective chart review design was selected.

It is anticipated that the medical charts will contain the information required to answer study objectives. This chart review study will be conducted in 25 sites in Italy An estimated total of 900 charts will be abstracted. This study requires no intervention or interference with standard medical care, and thus it will not affect patient treatment.

The study is sponsored by Italian Sarcoma Group Charts of patients who initiated trabectedin as part of the approved treatment for a Soft Tissue Sarcoma , will be identified by site staff. Each identified chart will be assigned a unique study identification number. Site staff will review the medical charts for all identified patients to determine patient eligibility. Those patients who meet eligibility criteria will be enrolled into the final study cohort as subject.

Data from subject medical charts will be abstracted by local site study staff and entered at the site into an electronic data capture (EDC) system. The system will also facilitate the monitoring of the completeness and quality of study data as the study data accrue.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who received trabectedin according to the approved indication in the period January 2010 December 2015

Exclusion criteria

  • Trabectedin started before January 2010 and after December 2015
  • Participation into clinical trials with trabectedin
  • Clinical chart missing, empty, or not retrievable.

Treatment and study plan

Trabectedin

Drug

Collection of data on the clinical use of Trabectedin

Other names: yondelis

Primary outcomes

  1. Post-trabectedin received treatment

    Time frame: Through treatment completion, an average of 24 month

    Number of chemotherapy lines received after trabectedin given according to the approved indication

Secondary outcomes

  1. Tumor response

    Time frame: after 6 months from trabectedin start date

    Percent of patients with non progressing disease at 6 months

  2. Trabectedin dose modification

    Time frame: Through treatment completion, an average of 24 month

    Describe trabectedin treatment experience in term of dose for patients with Soft Tissue Sarcoma treated with trabectedin as per market indication

  3. Progression-free survival

    Time frame: after 5 years and 3 years from trabectedin start date

    Describe progression-free survival (PFS) for patients with Soft Tissue Sarcoma who received trabectedin.

  4. Trabectedin safety profile

    Time frame: Through treatment completion, an average of 24 month

    Describe trabectedin safety profile in terms of number of participants with treatment-related adverse events as assessed by CTCAE v4.0 tha caused treatment discontinuation

  5. Overall survival

    Time frame: after 5 years and 3 years from trabectedin start date

    Describe overall survival (OS) for patients with Soft Tissue Sarcoma who received trabectedin.

Other outcomes

  1. Histology related treatment response

    Time frame: after 6 months from trabectedin start date

    Number of patient who did not progress based on the different Soft Tissue Sarcoma histology sub-type

Sponsors and collaborators

Lead sponsor

Italian Sarcoma Group

Network

Registry information

Official study title

Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)

Acronym: TrObs

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2016
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.