Retrospective Study of Trabectedin in Soft Tissue Sarcomas

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sarcoma, Soft Tissue

Intervention / Treatment
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* Drug: Trabectedin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trabectedin<br>Trabectedin give according the market authorization for advanced soft tissue sarcoma | Drug: Trabectedin<br>* Collection of data on the clinical use of Trabectedin<br>* Other names: yondelis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-trabectedin received treatment | 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 | Percent of patients with non progressing disease at 6 months | after 6 months from trabectedin start date | 
| Trabectedin dose modification | 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 | 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 | 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 | Describe overall survival (OS) for patients with Soft Tissue Sarcoma who received trabectedin. | after 5 years and 3 years from trabectedin start date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trabectedin, Soft Tissue Sarcoma, Observational