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Re: canis_star post# 84833

Tuesday, 11/22/2016 5:34:20 PM

Tuesday, November 22, 2016 5:34:20 PM

Post# of 817882
You wrote:

... Primary completion date mean, the estimated data for last patient to collect in Nov 2016. So that doesn't tell you whether the 248 events occurred or not. Isnt it ?
its not clear to me what data we are waiting for ? PFS or OS data or both ?



Did you take a look at the european trial register - Section E.5? ... see link below.
The trial is designed with PFS as the Primary end point, and "Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated when 248 events of progression or death have occurred"

Below you will also see info about the Secondary end point, Overall Survival, and "Timepoint(s) of evaluation of this end point
Overall survival will be assessed when 233 deaths have occurred."


https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE

E.5 End points
E.5.1 Primary end point(s)
Time to objective demonstration of disease progression or death,
measured from time of randomization (progression free survival, PFS),
in patients with no evidence of disease progression after external beam
radiation therapy with concurrent temozolomide chemotherapy.
E.5.1.1 Timepoint(s) of evaluation of this end point
The primary endpoint will be evaluated when 248 events of progression or death have occurred. in addition, two interim analyses will evaluate the endpoint when approximately 60% and 80% of the events have occurred.
E.5.2 Secondary end point(s)
Overall survival: In patients with no evidence of disease progression after external beam radiation therapy with concurrent temozolomide chemotherapy.
E.5.2.1 Timepoint(s) of evaluation of this end point
Overall survival will be assessed when 233 deaths have occurred.



And the USA clinical trial site shows:
https://clinicaltrials.gov/ct2/show/NCT00045968

Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)



So, unless some of the protocol has been changed without public knowledge, then it would appear that the estimated Primary Completion in November 2016 (at least the "Final data collection date for primary outcome measure") only relates to PFS, and has nothing to do with the secondary endpoint of Overall Survival.
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