Retrospective Study of Trabectedin in Soft Tissue Sarcomas

Completed

• Conditions: Sarcoma, Soft Tissue
• Interventions: Drug: Trabectedin

• Registration Number: NCT02793050
• Lead Sponsor: Italian Sarcoma Group

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Study Start: 2016-06-15
• Primary Completion: 2018-10-02
• Study Completion: 2018-10-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trabectedin	Trabectedin	Trabectedin give according the market authorization for advanced soft tissue sarcoma

Primary Outcome Measures

Name	Time	Method
Post-trabectedin received treatment	Through treatment completion, an average of 24 month	Number of chemotherapy lines received after trabectedin given according to the approved indication

Secondary Outcome Measures

Name	Time	Method
Tumor response	after 6 months from trabectedin start date	Percent of patients with non progressing disease at 6 months
Overall survival	after 5 years and 3 years from trabectedin start date	Describe overall survival (OS) for patients with Soft Tissue Sarcoma who received trabectedin.
Trabectedin dose modification	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
Progression-free survival	after 5 years and 3 years from trabectedin start date	Describe progression-free survival (PFS) for patients with Soft Tissue Sarcoma who received trabectedin.
Trabectedin safety profile	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

Trial Locations

Locations (26)

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

Istituto Tumori Giovanni Paolo II; 🇮🇹 Bari, BA, Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, BG, Italy

Ospedale Oncologico A. Businco; 🇮🇹 Cagliari, CA, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST; 🇮🇹 Meldola, FC, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milano, MI, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone; 🇮🇹 Palermo, PA, Italy

Centro di Riferimento Oncologico di Aviano; 🇮🇹 Aviano, PD, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, PD, Italy

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