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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01650077

Acronym

ProAcTyon

Enrollment

134

Registered

2012-07-26

Start date

2012-09-21

Completion date

2014-10-28

Last updated

2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Sarcoma

Keywords

Soft tissue sarcoma, Yondelis, Intolerance to doxorubicin/ifosfamide, CHOI criteria

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results