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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-21

Study Completion Date

2014-10-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Soft Tissue Sarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)