An observational study in Soft Tissue Sarcoma, sponsored by Centre Oscar Lambret. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by Centre Oscar Lambret · Observational
Non-interventional study consisting of a population of patients who had received for soft tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.
Patient selection is based on a database of retrospectively within the GSF / GETO.
The tumor assessment must be made by scanner at baseline and post-C2 or C3 and should be available and sent to sponsor.
The comparative reading of the imaging is centralized and made without the knowledge of the local assessment:
1,691 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 134 is close to the median of 125 across 244 observational studies indexed under Sarcoma.
Browse Sarcoma studies →Centre Oscar Lambret is the lead sponsor of 130 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To assess the feasibility of tumor response according to CHOI criteria
percentage of cases with a feasible evaluation according to CHOI
Time frame: after 6 weeks of treatment
To classify patients into two categories (progression or no progression) according to RECIST and to CHOI
percentage of cases with a feasible evaluation according to RECIST
Time frame: after 6 weeks of treatment
To determine percentage of false progression
define as patient progressing according to RECIST and not progressing according to CHOI number of patient in each categories, according to each method of measurement
Time frame: after 6 weeks of treatment
To determine predictive values of progression free survival and overall survival
progression free survival = median time between date of inclusion and date of clinical or radiological progression overall survival = median time between date of inclusion and date of death
Time frame: after 6 weeks of treatment
To characterize the profile of patients in false progression
patient in progression according to RECIST but not progressing according to CHOI
Time frame: after 6 weeks of treatment
Ran from Sep 2012 to primary completion in Dec 2013, 15 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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