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

niversity of Birmingham0 sites52 target enrollmentMarch 3, 2020

Overview

No summary available.

Registry

who.int

Start Date

March 3, 2020

End Date

June 30, 2027

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 23/11/2023:
•1\. Age \> 18 years old
•2\. Bodyweight \> 30 kg
•3\. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional cell carcinoma or squamous cell carcinoma)
•4\. Localised muscle\-invasive carcinoma either surgically or by imaging (T2\-T4a N0\-2 M0\)
•5\. World Health Organisation (WHO) performance status grade 0 to 1
•6\. Adequate normal organ and marrow function as defined below:
•6\.1\. Haemoglobin \> \= 100 g/L
•6\.2\. Absolute neutrophil count 1\.5 x 10^9/L
•6\.3\. Platelet count \> \= 100 x 10^9/L

•Current participant exclusion criteria as of 20/09/2023:
•1\. Uncontrolled systemic disease which would preclude the patient from participating in the trial including severe or uncontrolled cardiovascular disease
•2\. Restrictive or obstructive disturbances to pulmonary ventilation, renal function or liver function
•3\. Previous pelvic radiotherapy
•4\. Bilateral hip replacements compromising accurate radiotherapy planning
•5\. Evidence of significant clinical disorder, or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
•6\. Widespread Carcinoma in situ (CIS), or CIS remote from the muscle\-invasive tumour
•7\. Untreated hydronephrosis. Patients with hydronephrosis can be included if the kidney/ureter has been stented or nephrostomy has been inserted
•8\. Prior participation in another trial (within the previous 30 days) or concurrent enrolment in another clinical trial, unless it is an observational (non\-interventional) clinical study or during the follow\-up period of an interventional study
•9\. Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) Grade \> \= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria (see protocol for exceptions)