Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
ProAcTyon
Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility
1 other identifier
observational
134
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedStudy Start
First participant enrolled
September 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2014
CompletedMay 14, 2019
May 1, 2019
1.2 years
July 19, 2012
May 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the feasibility of tumor response according to CHOI criteria
percentage of cases with a feasible evaluation according to CHOI
after 6 weeks of treatment
Secondary Outcomes (4)
To classify patients into two categories (progression or no progression) according to RECIST and to CHOI
after 6 weeks of treatment
To determine percentage of false progression
after 6 weeks of treatment
To determine predictive values of progression free survival and overall survival
after 6 weeks of treatment
To characterize the profile of patients in false progression
after 6 weeks of treatment
Eligibility Criteria
Patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide
You may qualify if:
- 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)
You may not qualify if:
- Gastro Intestinal Stromal Tumor GIST
- primitive bone sarcoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Bergonie Institute
Bordeaux, 33 076, France
Oscar Lambret Center
Lille, 59020, France
Antoine Lacassagne Center
Nice, 06 189, France
Curie Institute
Paris, 75 005, France
Henri Becquerel Center
Rouen, 76 038, France
Cancer Institute of the West
Saint-Herblain, 44 805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicolas PENEL, MD
Oscar Lambret Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 26, 2012
Study Start
September 21, 2012
Primary Completion
December 1, 2013
Study Completion
October 28, 2014
Last Updated
May 14, 2019
Record last verified: 2019-05