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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01650077
Other study ID # ProAcTyon - 1203
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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