Ramsesthenice, with all due respect to your concerns, please read my replies in full as written in the Rad Onc Twitter thread starting on April 10, and avoid editorializing without knowing the reality of such issues. I'll summarize for you here. I'm neither a statistician nor work at any proton center but this is based on my own hard work to think and reason things out myself.
I've personally been waiting forever for people to actually think outside the box for new endpoints instead of the same old junk. Making an endpoint like "CTCAE grade 3+ cardiopulmonary events" requires an absurd sample size and does not take into account the duration and severity of those side effects. In other words, if you're enrolled in a trial that has the CTCAE based endpoint, and you happen to get a grade 3 lung toxicity... Followed by a grade 4 cardiac event, grade 4 sepsis, grade 4 anastomotic leak, etc, it's counted the same way as a patient who got grade 3 lung toxicity and nothing else. Is this the right way to conduct a trial? I think not. Only TTB actually encompasses all these things that could happen for x period of time after CRT or surgery. Do NOT rest your hopes on GI 006 because of CTEP as I wrote in that thread. TTB is the only measure that looks at the "overall picture" which CTEP sadly cannot understand. CTCAE only captures one aspect of toxicities and it's woefully inadequate because the "value" of that endpoint to patients is nothing close to TTB. Like I said in that thread, if the patient is someone I know, I'm not even considering IMRT anymore. "Moving the goalposts" is an absolutely inane way to look at this..."moving the goalposts" is what Dan Spratt does with post hoc (retrospective) analyses before convincing you that his findings are real. That trial was NOT moving the goalposts. It's time to finally wisen up to the fact that protons are going to be a clear failure for some sites (prostate, breast), and advantageous for others (esophagus), and the rest TBD; even within a particular site there will be cases which benefit and cases that won't benefit, so there's little point in generalizing that protons are all good or all bad. Same with any oncologic therapy, even immunotherapy. That's life for you.