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

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ClinicalTrials.gov Identifier: NCT01650077
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Study Description
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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.

Condition or disease
Soft Tissue Sarcoma

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.
Study Design
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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility
Actual Study Start Date : September 21, 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : October 28, 2014

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the feasibility of tumor response according to CHOI criteria [ Time Frame: after 6 weeks of treatment ]
    percentage of cases with a feasible evaluation according to CHOI


Secondary Outcome Measures :
  1. To classify patients into two categories (progression or no progression) according to RECIST and to CHOI [ Time Frame: after 6 weeks of treatment ]
    percentage of cases with a feasible evaluation according to RECIST

  2. To determine percentage of false progression [ Time Frame: 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

  3. To determine predictive values of progression free survival and overall survival [ Time Frame: 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

  4. To characterize the profile of patients in false progression [ Time Frame: after 6 weeks of treatment ]
    patient in progression according to RECIST but not progressing according to CHOI


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650077


Locations
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France
Bergonie Institute
Bordeaux, France, 33 076
Oscar Lambret Center
Lille, France, 59020
Antoine Lacassagne Center
Nice, France, 06 189
Curie Institute
Paris, France, 75 005
Henri Becquerel Center
Rouen, France, 76 038
Cancer Institute of the West
Saint-Herblain, France, 44 805
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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Study Director: Nicolas PENEL, MD Oscar Lambret Center
More Information
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01650077    
Other Study ID Numbers: ProAcTyon - 1203
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Keywords provided by Centre Oscar Lambret:
Soft tissue sarcoma
Yondelis
Intolerance to doxorubicin/ifosfamide
CHOI criteria
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms