Rad-IO
Research type
Research Study
Full title
A multi-stage randomised trial of durvalumab (Medi4736) with chemoradiotherapy with 5-fluorouracil and mitomycin C in patients with muscle-invasive bladder cancer
IRAS ID
251669
Contact name
Nicholas James
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2018-003520-37
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Bladder cancer is the ninth most common cancer diagnosed worldwide. Approximately 24% of patients have muscle invasive bladder cancer (cancer that has grown into the muscle layer of the bladder wall). Five-year survival rates are around 45%. The current standard of treatment for muscle invasive bladder cancer consists of radiotherapy given with chemotherapy, 5-Fluorouracil (5FU) and Mitomycin C (MMC), so called chemoradiotherapy.
Recent research has shown that immunotherapy drugs may activate the body’s immune system and slow down cancer growth. Durvalumab is one such drug, which is licenced for use in non-small cell lung cancer. It has been shown to be well tolerated when given with radiotherapy.
Rad-IO is a randomised, multicentre, multi-arm, multi-stage clinical trial designed to assess whether giving durvalumab in addition to chemoradiotherapy improves the outcome of patients with muscle invasive bladder cancer without increasing toxicity. There are three stages to the trial:
Stage 1: assesses feasibility and safety.
Stage 2: assesses disease free-survival (length of time after treatment the patient survives without any signs or symptoms of their cancer) in a phase II trial setting.
Stage 3: if stage 2 is successful the trial will roll into a phase III, assessing overall survival (length of time from trial entry to death from any cause) with the option to add new arms.
Patients 18 years or over who have muscle invasive bladder cancer, who are fit enough to receive the trial treatment, and who consent to take part, will be randomly allocated to receive chemoradiotherapy given as standard over a period of 4 weeks, or chemoradiotherapy with durvalumab (given for 12 months). Stages 1&2 will recruit 159 patients.
Patients will also be asked to take part in a quality of life sub-study and donate tumour samples. They will be followed up for a period of 5 years.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0379
Date of REC Opinion
7 Feb 2020
REC opinion
Further Information Favourable Opinion