Retrospective Study of Trabectedin in Soft Tissue Sarcomas (TrObs)

May 9, 2019 updated by: Italian Sarcoma Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli
      • Bologna, Italy, 40138
        • Policlinico S.Orsola Malpighi - Unit of Medical Oncology
      • Brescia (BS), Italy
        • Pres.Ospedal.Spedali Civili Brescia -
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Milano (MI), Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int)
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena - Policlinico
      • Napoli (NA), Italy
        • Irccs Istituto Nazionale Tumori Fondazione Pascale -
      • Prato, Italy, 59100
        • Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4
      • Reggio EMilia, Italy, 42123
        • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario "Agostino Gemelli"
      • Rome, Italy, 00100
        • Istituto Regina Elena - IFO
      • Torino, Italy, 10126
        • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
      • Torino (TO), Italy
        • Presidio Sanitario Gradenigo Di Torino
    • AL
      • Alessandria, AL, Italy, 15100
        • A.O. SS Antonio e Biagio e Cesare Arrigo
    • BA
      • Bari, BA, Italy, 70124
        • Istituto Tumori Giovanni Paolo II
    • BG
      • Bergamo, BG, Italy
        • Ospedali Riuniti di Bergamo
    • CA
      • Cagliari, CA, Italy, 09122
        • Ospedale Oncologico A. Businco
    • FC
      • Meldola, FC, Italy
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
    • MI
      • Milano, MI, Italy, 20141
        • Istituto Europeo di Oncologia
      • Rozzano, MI, Italy, 20089
        • Istituto Clinico Humanitas
    • PA
      • Palermo, PA, Italy, 90127
        • Azienda ospedaliera universitaria paolo giaccone
    • PD
      • Aviano, PD, Italy, 33081
        • Centro di Riferimento Oncologico di Aviano
      • Padova, PD, Italy, 35128
        • Istituto Oncologico Veneto
    • PI
      • Pisa, PI, Italy, 56124
        • Azienda Ospedaliera Universitaria Santa Chiara
    • RM
      • Roma, RM, Italy, 00128
        • Policlinico Universitario Campus Biomedico
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced soft tissue sarcoma who received trabectedin according its market authorisation, in Italy from 01Jan2010 to 31Dec2015

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trabectedin
Trabectedin give according the market authorization for advanced soft tissue sarcoma
Drug: Trabectedin
Collection of data on the clinical use of Trabectedin
Other Names:
  • yondelis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through treatment completion, an average of 24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: after 6 months from trabectedin start date
Percent of patients with non progressing disease at 6 months
after 6 months from trabectedin start date
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
Through treatment completion, an average of 24 month
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.
after 5 years and 3 years from trabectedin start date
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
Through treatment completion, an average of 24 month
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.
after 5 years and 3 years from trabectedin start date

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 6 months from trabectedin start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2016

Primary Completion (Actual)

October 2, 2018

Study Completion (Actual)

October 2, 2018

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISG TrObs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Aggregate anonymized results will be available upon request at the end of the study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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