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

Soft Tissue Sarcoma Clinical Trial

— ProAcTyon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650077
• Other study ID #: ProAcTyon - 1203
• Status: Completed
• Start date: September 21, 2012
• Est. completion date: October 28, 2014

Study information

• Verified date: May 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 28, 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Locations

Country	Name	City	State
France	Bergonie Institute	Bordeaux
France	Oscar Lambret Center	Lille
France	Antoine Lacassagne Center	Nice
France	Curie Institute	Paris
France	Henri Becquerel Center	Rouen
France	Cancer Institute of the West	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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