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Re: djs7 post# 221359

Saturday, 03/17/2018 10:28:18 AM

Saturday, March 17, 2018 10:28:18 AM

Post# of 403072
Correct. I interpreted Galera's swimlanes. I am, as you seem to be, waiting some kind of publication of their p2 results. Nothing, so far, at ClinicalTrials.gov. But the filing has one interesting tidbit:

Galera likes to publish it's trial minimum cumulative radiation requirement as 60 Gy. At first glance that looks like higher requirement than IPIX's 55 Gy. But IPIX's minimum is for ORAL CAVITY (ie. the target environment) while GALERA ALWAYS publishes numbers for TUMOR (ie. the target only). In the filing at ClinicalTrials GALERA lists the minimum for oral cavity as 50 Gy.

"Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 50 Gy"


This is important because SOM incidence rate and probably also duration goes up with cumulative radiation dose --> GALERA's published results seem to be for less demanding setting than those reported by IPIX.

Impressive for oral rinse.
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