This trial is active, not recruiting.

Condition soft tissue sarcoma
Sponsor Centre Oscar Lambret
Start date September 2012
End date December 2013
Trial size 134 participants
Trial identifier NCT01650077, ProAcTyon - 1203


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

To assess the feasibility of tumor response according to CHOI criteria
time frame: after 6 weeks of treatment

Secondary Outcomes

To classify patients into two categories (progression or no progression) according to RECIST and to CHOI
time frame: after 6 weeks of treatment
To determine percentage of false progression
time frame: after 6 weeks of treatment
To determine predictive values of progression free survival and overall survival
time frame: after 6 weeks of treatment
To characterize the profile of patients in false progression
time frame: after 6 weeks of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.