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Title

A Phase III randomised control clinical trial of radiotherapy with radiosensitisation versus intravesical Bacillus Calmette-Guerin therapy for high-risk non-muscle invasive bladder cancer.

Description

For patients with High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC), the usual treatment is surgery to remove the tumour (TURBT) followed by BCG immunotherapy given into the bladder, or bladder removal (cystectomy). BCG is given over several weeks with maintenance for up to three years. However, up to half of patients relapse of progress after BCG, and 25% stop treatmentÌýdue to side-effects. In addition, worldwide shortages of BCG have made treatment less reliable.

New options are needed to reduce recurrence, avoid bladder removal, and overcome supply issues. One alternative is trimodality treatment (TURBT + radiotherapy + radiosensitiser drug). This approach works as well as cystectomy in muscle-invasive bladder cancer, but has not been tested routinely in HR-NMIBC. Early studies suggest it may prevent recurrence in more than half of patients over five years, with modern radiotherapy expected to further reduce side-effects.

The TRAIN trial will compare BCG with radiotherapy plus radiosensitisation in 328 HR-NMIBC patients. Patients will be followed for at least two years to assess outcomes.

Objectives

Primary Objectives:

To compare event-free survival between BCG and radiotherapy with radiosensitisation.

Secondary Objectives:

• To compare each component of the primary outcome between BCG and radiotherapy with radiosensitisation.
• To determine the difference between BCG and radiotherapy with radiosensitisation for patient-reported symptoms.
• To determine the difference in cancer specific survival between groups.
• To establish tolerability and safety of radiotherapy with radiosensitisation.
• To determine the difference in treatment fidelity between the groups.
• To determine the cost-effectiveness of radiotherapy with radiosensitisation compared to BCG.

Trial Design