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

May 13, 2019 updated by: Centre Oscar Lambret

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33 076
        • Bergonie Institute
      • Lille, France, 59020
        • Oscar Lambret Center
      • Nice, France, 06 189
        • Antoine Lacassagne Center
      • Paris, France, 75 005
        • Curie Institute
      • Rouen, France, 76 038
        • Henri Becquerel Center
      • Saint-Herblain, France, 44 805
        • Cancer Institute of the West

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 6 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 6 weeks of treatment
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
after 6 weeks of treatment
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
after 6 weeks of treatment
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
after 6 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Study Director: Nicolas PENEL, MD, Oscar Lambret Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

October 28, 2014

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProAcTyon - 1203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Soft Tissue Sarcoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe