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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01650077
First received: July 19, 2012
Last updated: March 6, 2014
Last verified: July 2013

July 19, 2012
March 6, 2014
September 2012
December 2013   (final data collection date for primary outcome measure)
To assess the feasibility of tumor response according to CHOI criteria [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
percentage of cases with a feasible evaluation according to CHOI
evaluate feasibility of measuring tumor according to CHOI criteria [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
percentage of cases with a feasible evaluation according to CHOI
Complete list of historical versions of study NCT01650077 on ClinicalTrials.gov Archive Site
  • To classify patients into two categories (progression or no progression) according to RECIST and to CHOI [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    percentage of cases with a feasible evaluation according to RECIST
  • To determine percentage of false progression [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    patient in progression according to RECIST but not progressing according to CHOI
  • classify patients into two categories (progression or no progression) according to RECIST and to CHOI [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    percentage of cases with a feasible evaluation according to RECIST
  • determine percentage of false progression [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    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
  • determine predictive values of progression free survival and overall survival [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    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
  • characterize the profile of patients in false progression [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
    = patient in progression according to RECIST but not progressing according to CHOI
Not Provided
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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

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

Patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide

Soft Tissue Sarcoma
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01650077
ProAcTyon - 1203
No
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Study Director: Nicolas PENEL, MD Oscar Lambret Center
Centre Oscar Lambret
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP