Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: sum of the large diameter for 2 imagery (baseline and 1st evaluation tumor density on areas of interest for the 2 imaging (baseline and 1st evaluation Rank patients according to two methods (Choi and RECIST): complete response, partial response, stability, progress and non-assessable.

Official Title
-----------------
Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility

Conditions
-----------------
Soft Tissue Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years locally advanced or metastatic soft tissue sarcoma treated with Yondelis after failure or intolerance to doxorubicin/ifosfamide treated between 2007 and 2011 have had at least 2 cycles of Yondelis assessment of tumor by CT scan (baseline and after 2 or 3 cycles of Yondelis) Exclusion Criteria: Gastro Intestinal Stromal Tumor GIST primitive bone sarcoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of tumor response according to CHOI criteria | percentage of cases with a feasible evaluation according to CHOI | after 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | after 6 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft tissue sarcoma, Yondelis, Intolerance to doxorubicin/ifosfamide, CHOI criteria