CEDAR: Chemoradiation with Enadenotucirev as a radiosensitiser in locally advanced colorectal cancer
This phase I study will test the combination of a novel oncolytic virus (Enadenotucirev) with radical chemoradiation, prior to surgery in patients with locally advanced rectal cancer who are deemed suitable for curative treatment. Research Question: Is the combination of Enadenotucirev (EnAd) radical radiotherapy safe and tolerable in locally advanced rectal cancer? Primary Objective: To determine the safety, toxicity profile and MTD (or phase II dose if MTD not reached) of Enadenotucirev administered concomitantly with chemoradiation (CRT) for locally advanced rectal cancer. Primary endpoint: The highest number schedule that has no more than 30% grade 3 and 4 toxicity. DLT will be defined as per NCI CTCAE v4.03 and include Grade ≥4 Haem toxicity, Grade ≥4 GI toxicity within 2 weeks of starting radiotherapy, any grade ≥4 considered related to study treatment, including pneumonitis, or other cytokine release syndrome.