1)" iRANO is used to account for pseudo progression vs. true progression" -- Reefrad
Your memory is short, we went over this. This trial is determinig patients PFS event based on scans at the time of the visit. Confirmation scans are not being used. They are changing iRANO to account for immunotherapy, based on lessons learned during immunotherapy trials. Only this trial is near the end of enrollment.
Journal of Neuro-Oncology July 2015 addition, within it, is the article written in Feb 2015, "RE-DEFINING RESPONSE AND TREATMENT EFFECTS FOR NEURO-ONCOLOGY IMMUNOTHERAPY TRIALS". Their paper specifically addresses the pseudo-progression in the main arm: "the complexity of radiographic worsening following immunotherapy".
I believe that the current halt potentially has something to do with incorporating these new iRANO neuro-oncolgoy changes within the trial. You are free to disagree.
No one is saying iRANO can help if patients are living longer. The idea is to make sure they are not removing patients prematurely from the main arm. And the fact that they may have removed a few means that their primary endpoint took a hit. Adding a co-endpoint will fix that. If regulators allow them to, it's a good thing.
I actually did research on it. The first 10 sites that signed up did. Take a look and see for yourself.
The Company was very strategic on the sites that they added to the study.One of the reasons I bought back in, as I understood that a better surgery means greater chance for success on OS with immunotherapy.
More and more sites are getting the state of the art equipment or do a FGS. And, just so you know, as you probably do not, when NW Bio adds a site, it does not mean that the patient has their surgery there. If you followed the NCT clinical site, you would have seen a specific contact listed at multiple sites. An interested patient might contact someone at let's say Stony Brook Hospital, and end reaching out to someone that works at Long Island Brain Tumor Center at Neurological Surgery, P.C, where they have state of the art diagnostic and surgical equipment.