NCT01650077

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcoma

Timeline

• Start date: 2012-09-21
• Primary completion: 2013-12-01
• Completion: 2014-10-28
• First posted: 2012-07-26
• Last updated: 2019-05-14

Locations

6 sites across 1 country: France