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

Completed

• Conditions: Soft Tissue Sarcoma

• Registration Number: NCT01650077
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Study Start: 2012-09-21
• Primary Completion: 2013-12
• Study Completion: 2014-10-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of tumor response according to CHOI criteria	after 6 weeks of treatment	percentage of cases with a feasible evaluation according to CHOI

Secondary Outcome Measures

Name	Time	Method
To classify patients into two categories (progression or no progression) according to RECIST and to CHOI	after 6 weeks of treatment	percentage of cases with a feasible evaluation according to RECIST
To determine percentage of false progression	after 6 weeks of treatment	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
To determine predictive values of progression free survival and overall survival	after 6 weeks of treatment	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
To characterize the profile of patients in false progression	after 6 weeks of treatment	patient in progression according to RECIST but not progressing according to CHOI

Trial Locations

Locations (6)

Oscar Lambret Center; 🇫🇷 Lille, France

Bergonie Institute; 🇫🇷 Bordeaux, France

Curie Institute; 🇫🇷 Paris, France

Antoine Lacassagne Center; 🇫🇷 Nice, France

Cancer Institute of the West; 🇫🇷 Saint-Herblain, France

Henri Becquerel Center; 🇫🇷 Rouen, France