-"Who is discussing living longer we are discussing your 3 year time frame."
Sorry, misinterpreted the meaning behind your first post comparing 60 to 600+. Now I understand your concern is about recruitment time.
-"12 months to recruit 60 patients for the Phase2b trial. Patients who were already in remission. 5 months into the Phase2/3 trial and we have 10 study locations out of the current 95 study locations recruiting. "
Hard to compare recruitment rates between the 2 phases. Phase III is recruiting at many more centres over a wider geographical range. The pool of potential patients is significantly larger. In theory, at least.
-"Recruiting patients having to undergo leukapheresis prior to commencing months of chemotherapy and they can't receive their first dose of Cvac unless they gain complete remission, so some may not progress."
~80% of OC patients go into remission after aggressive surgery and 1st line chemo. (Presumably why the study is recruiting 1000 to get 800).
-"the FDA is not going to approve Cvac based on PFS... if there is no improvement in Overall Survival rates ... so therefore OS data will be required and that won't happen in your 3 year time frame at this rate."
Median overall survival for OC is 2.95 years.
-"Cvac is administered after first-line chemo and after the patient is in complete remission, if not in complete remission they do not qualify"
As above.
-"Yes median survival may be just under 3 years but overall survival is certainly not."
2.95 is the median overall survival rate. They're not 2 separate things.
-"Most patients with ovarian cancer achieve complete clinical remission after optimal debulking surgery and platinum-based chemotherapy. However, most patients, despite high response rates to first-line treatment, will relapse and undergo subsequent lines of chemotherapy. Generally, the progression-free interval between treatments becomes shorter with each relapse, and the patient eventually dies of the disease... http://clinicaltrials.gov/archive/NCT01521143/2012_06_05"
Not sure what you're suggesting with that quote that doesn't confirm that the timeline for PFS will be short due to the aggressive nature of OC.
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Regardless of what either of us say above, the irrefutable fact is clinicaltrials site still states study completion in 2015. With trial duration UP TO 156 weeks (3 years). Here, i'll help you with it... in fact, it's even from the link you posted above...;)
............................................................................................................... Primary outcome Measure: Progression-free survival (PFS) for maintenance treatment of patients with EOC in complete remission following first-line chemotherapy Time Frame: From date of randomization until the date of first documented progression, date of death from any cause, or end of study, whichever comes first, assessed up to 156 weeks
Secondary outcome Measure: Overall survival (OS) Time Frame: Participants will be followed from randomization until the date of death from any cause or end of study, whichever comes first, assesessed up to 156 weeks.
Secondary outcome Measure: Assessment of safety and tolerability of Cvac as compared to placebo Time Frame: 10 - 12 months
Secondary outcome Measure: Assessment of health-related quality of life questionnaires(QoL) Time Frame: From baseline and throughout PFS up to 156 weeks ...................................................................................................................
The key factor there is the start point being "date of randomization". This will happen after surgery, but before leukapheresis and chemo. Up to 156 weeks from that date is the study length, or earlier. So, you can understand why this 3 year figure keeps popping up.
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