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
  Purpose

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
Soft Tissue Sarcoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650077

Locations
France
Bergonie Institute
Bordeaux, France, 33 076
Oscar Lambret Center
Lille, France, 59020
Cancer Institute of the West
Nantes - Saint Therblain, France, 44 805
Antoine Lacassagne Center
Nice, France, 06 189
Curie Institute
Paris, France, 75 005
Henri Becquerel Center
Rouen, France, 76 038
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Nicolas PENEL, MD Oscar Lambret Center
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01650077     History of Changes
Other Study ID Numbers: ProAcTyon - 1203
Study First Received: July 19, 2012
Last Updated: March 6, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Oscar Lambret:
Soft tissue sarcoma
Yondelis
Intolerance to doxorubicin/ifosfamide
CHOI criteria

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 01, 2014