Soft Tissue SarcomaProAcTyonNCT01650077
Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
An observational study of Soft Tissue Sarcoma, run by Centre Oscar Lambret at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- How many people
- 134 participants
- Where
- 6 sitesFrance
- Study dates
- 21 Sep 2012to 28 Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide
Who may be able to join
- 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)
Who cannot join
- Gastro Intestinal Stromal Tumor GIST
- primitive bone sarcoma
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Bergonie Institute
Bordeaux, 33 076
Oscar Lambret Center
Lille, 59020
Antoine Lacassagne Center
Nice, 06 189
Curie Institute
Paris, 75 005
Henri Becquerel Center
Rouen, 76 038
Cancer Institute of the West
Saint-Herblain, 44 805
About this study
Official title: 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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft tissue sarcoma, Yondelis, Intolerance to doxorubicin/ifosfamide, CHOI criteria
- Medical subject headings
- Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of tumor response according to CHOI criteria
percentage of cases with a feasible evaluation according to CHOI
Measured: after 6 weeks of treatment
Secondary outcomes (4)
To classify patients into two categories (progression or no progression) according to RECIST and to CHOI
percentage of cases with a feasible evaluation according to RECIST
Measured: after 6 weeks of treatment
To determine percentage of false progression
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
Measured: after 6 weeks of treatment
To determine predictive values of progression free survival and overall survival
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
Measured: after 6 weeks of treatment
To characterize the profile of patients in false progression
patient in progression according to RECIST but not progressing according to CHOI
Measured: after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study start21 Sep 2012
- Primary completionDec 2013
- Study completion28 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas PENEL, MD, Study director, Oscar Lambret Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650077
- Sponsor's protocol ID
- ProAcTyon - 1203
- Acronym
- ProAcTyon
- Status last verified
- May 2019
- First submitted
- 19 Jul 2012
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility
- ClinicalTrials.gov ID
- NCT01650077
- Acronym / sponsor ID
- ProAcTyon / ProAcTyon - 1203
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft tissue sarcoma, Yondelis, Intolerance to doxorubicin/ifosfamide, CHOI criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 21 Sep 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- 28 Oct 2014 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Gastro Intestinal Stromal Tumor GIST
- primitive bone sarcoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
To classify patients into two categories (progression or no progression) according to RECIST and to CHOI
Time frame: after 6 weeks of treatment
To determine percentage of false progression
Time frame: after 6 weeks of treatment
To determine predictive values of progression free survival and overall survival
Time frame: after 6 weeks of treatment
To characterize the profile of patients in false progression
Time frame: after 6 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas PENEL, MD study director
Oscar Lambret Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma, run by Centre Oscar Lambret at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of tumor response according to CHOI criteria (time frame: after 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.