TUXEDO: A phase I/II trial of cetuximab with chemoradiotherapy in muscle-invasive bladder cancer.

ABSTRACT:

Objective

To assess feasibility and preliminary efficacy of adding cetuximab to standard chemoradiotherapy for muscle-invasive bladder cancer.

Patients and methods

TUXEDO was a prospective, single-arm, open-label, phase I/II trial conducted in six UK hospitals. Cetuximab was administered with an initial loading dose of 400mg/m² on day 1 of week -1, and then 7-weekly doses of 250mg/m² . Radiotherapy schedule was 64Gy/32F with day 1 mitomycin C (12g/m² ) and 5-fluorouracil (500mg/m² /day) over days 1-5 and 22-26. Patients with T2-4aN0M0 urothelial cancer and a performance status (PS) of 0-1 were eligible. Prior neoadjuvant therapy was permitted. The phase I primary outcome was impact on radiotherapy treatment completion and toxicity

SUBMITTER: James ND 

PROVIDER: S-EPMC10087008 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature