TUXEDO: Phase I/II feasibility study of cetuximab with 5FU and mitomycin C or cisplatin with concurrent radiotherapy in muscle invasive bladder cancer

Trial Overview and Summary

Chief Investigator: Professor Nicholas James
Sponsor: University of Birmingham
Funders: Cancer Research UK
Disease Site: Bladder Cancer
Trial Type: Chemoradiotherapy / Phase II
Status: Closed, 6th September 2018
UKCRN Study ID: (if applicable) 7949
Recruitment start date: 06 July 2012
Recruitment end date: 31st October 2016
CRCTU Trial Management Team: Team A
Trial E-mail Address: tuxedo@trials.bham.ac.uk

Muscle invasive bladder cancer describes bladder cancer which has grown into the muscle layer of the bladder wall. This is usually treated with chemotherapy and radiotherapy.

The trial is looking at combining radiotherapy with a monoclonal antibody called cetuximab given alongside standard chemotherapy drugs. Following successful phase I results where a combination of the chemotherapy drugs, 5-FU and mitomycin C, were delivered alongside cetuximab and radiotherapy, this treatment regimen is now being tested in a phase II setting to find out if it works better at preventing bladder recurrence than the current standard treatment. 

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible

Trial Protocol

Please Note:

Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

More information