A multi-stage randomised trial of duvalumab (Medi4736) with chemoradiotherapy with 5-Fluorouracil and mitomycin C in patients with muscle invasive bladder cancer

Trial summary:

RadIO is a rolling phase II/III randomised control trial with an integral pilot phase that aims to assess the safety, feasibility and efficacy of a combination of radiotherapy with durvalumab (a type of immunotherapy) and chemotherapy in muscle-invasive bladder cancer.

Patients who fulfil the eligibility criteria will be randomised to either the Control Arm (chemoradiotherapy) or the Research Arm (durvalumab + chemoradiotherapy). 159 patients will be recruited over 2 years.

RT QA summary:

All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.

QA ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case
Planning Benchmark Case
Dummy Run
During AccrualIndividual Case ReviewProspective: First patient for centres/clinicians who have not participated in previous bladder radiotherapy clinical trials
Data collectionAll patients
QA StreamliningRAIDER

RTTQA contact: Radioqa.enh-tr@qawebmod

Chief investigator: Professor Nicholas James, The Institute of Cancer Research, London

Sponsor: University of Birmingham, RadIO@trials.bham.ac.uk

Funder: AstraZeneca/MedImmune