Design specifications
toxicity
Acute GI and GU toxicity are being assessed according to both the CTCAE, version 5.0, and the PRO-CTCAE. A C-DLT is defined as an acute grade 3 or higher GI or GU per CTCAE and a P-DLT is defined by GI toxicity with a score of 4 or 5 on the 5-point scale per PRO-CTCAE, occurring within three months of completing WPRT. The MTD is defined as the minimum of the dose with a C-DLT rate closest to the clinician-reported target C-DLT rate of 