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SO Séan M. O’Cathail
SD Steven Davis
JH Jane Holmes
RB Richard Brown
KF Kerry Fisher
LS Leonard Seymour
RA Richard Adams
JG James Good
DS David Sebag-Montefiore
TM Tim Maughan
MH Maria A. Hawkins
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To determine the optimal dose and frequency of enadenotucirev that can be administered with chemoradiation for rectal cancer.

Primary Endpoints

Dose limiting toxicity

MRI tumour regression grade

Secondary Endpoints

Ability to deliver enadenotucirev concurrently with chemoradiation

Assessment of treatment tolerance as measured by the proportion of patients completing at least 80% of the intended Capecitabine dose and at least 20 fractions of radiotherapy by the end of week 9

To measure local response rate to combined therapy compared to pre-treatment status

Pathological complete response rate

Neoadjuvant rectal (NAR) score [35]

Exploratory Endpoints

To identify ‘proof of concept’ that enadenotucirev replicates in the tumour during chemoradiotherapy

IHC staining of hexon protein coat in tumour cells from ‘on-treat’ biopsy performed on week 2 of radiotherapy

Copyright and License information: The Author(s) ©2020
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