drugset / Trial / NCT02070120

Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer

NCT02070120

RandomizedParallel-groupOpen-labelTreatment

Summary

Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic. This multicentre study aims to establish the short term efficacy of chemoresection using chemotherapy within the bladder for the treatment of NMIBC. Should the levels of complete response following chemoresection meet predefined criteria, a larger phase III trial would be developed to assess longer term disease related endpoints, with the aim of standardising management of recurrent low risk NMIBC and potentially removing the need for over a thousand patients each year to undergo surgery.

Timeline

Start
2014-10
Primary completion
2018-01
Completion
2020-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 40 mg Other