|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02793050 |
|
Date of registration:
|
25/05/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Retrospective Study of Trabectedin in Soft Tissue Sarcomas
TrObs |
|
Scientific title:
|
Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs) |
|
Date of first enrolment:
|
June 15, 2016 |
|
Target sample size:
|
510 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02793050 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Stefano Ferrari, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Italian Sarcoma Group |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Sarcoma, Soft Tissue
|
|
Intervention(s)
|
|
Drug: Trabectedin
|
|
Primary Outcome(s)
|
|
Post-trabectedin received treatment
[Time Frame: Through treatment completion, an average of 24 month]
|
|
Secondary Outcome(s)
|
|
Progression-free survival
[Time Frame: after 5 years and 3 years from trabectedin start date]
|
|
Tumor response
[Time Frame: after 6 months from trabectedin start date]
|
|
Trabectedin dose modification
[Time Frame: Through treatment completion, an average of 24 month]
|
|
Trabectedin safety profile
[Time Frame: Through treatment completion, an average of 24 month]
|
|
Overall survival
[Time Frame: after 5 years and 3 years from trabectedin start date]
|
|
Secondary ID(s)
|
|
ISG TrObs
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|