Clinical trial NCT01650077: Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
Official title: Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma
Keywords: Soft tissue sarcoma
Yondelis
Intolerance to doxorubicin/ifosfamide
CHOI criteria
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the feasibility of tumor response according to CHOI criteria
timeFrame: after 6 weeks of treatment
Secondary outcomes:
measure: To classify patients into two categories (progression or no progression) according to RECIST and to CHOI
timeFrame: after 6 weeks of treatment
measure: To determine percentage of false progression
timeFrame: after 6 weeks of treatment
measure: To determine predictive values of progression free survival and overall survival
timeFrame: after 6 weeks of treatment
measure: To characterize the profile of patients in false progression
timeFrame: after 6 weeks of treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bergonie Institute
city: Lille
country: France
facility: Oscar Lambret Center
city: Nice
country: France
facility: Antoine Lacassagne Center
city: Paris
country: France
facility: Curie Institute
city: Rouen
country: France
facility: Henri Becquerel Center
city: Saint-Herblain
country: France
facility: Cancer Institute of the West
Study officials:
affiliation: Oscar Lambret Center
name: Nicolas PENEL, MD
role: STUDY_DIRECTOR
References: