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Retrospective Study of Trabectedin in Soft Tissue Sarcomas (TrObs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02793050
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

Study Description
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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.


Condition or disease Intervention/treatment
Sarcoma, Soft Tissue Drug: Trabectedin

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 Design
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Study Type : Observational
Actual Enrollment : 510 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : October 2, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Trabectedin

Groups and Cohorts
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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 Name: yondelis


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793050


Locations
Show Show 26 study locations
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
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Principal Investigator: Stefano Ferrari, MD Italian Sarcoma Group
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02793050    
Other Study ID Numbers: ISG TrObs
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Aggregate anonymized results will be available upon request at the end of the study
Keywords provided by Italian Sarcoma Group:
Trabectedin
Soft Tissue Sarcoma
Observational
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Trabectedin
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents