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Completed

NCT Number: NCT01650077

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

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.

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Key information

Conditions

Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergonie Institute, Bordeaux, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility

Acronym: ProAcTyon

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 26, 2012
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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