The investigators aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has yet to be fully explored.
18 years or older with histologically confirmed, BCG-unresponsive, high-risk non-muscle-invasive bladder cancer of predominantly (>50%) urothelial histology who were ineligible for or declined to undergo radical cystectomy
Patients with carcinoma in situ with or without high-grade Ta or T1
Eastern Cooperative Oncology Group performance status of 0-2, and adequate organ function
Patients with concomitant Ta and T1 tumours must have undergone complete TURBT, defined as per standard of care as a visually complete resection (residual carcinoma in situ, which is traditionally not amenable to complete transurethral resection is acceptable), and the most recent cystoscopy or TURBT must have been done within 12 weeks before study initiation. Presence of detrusor muscle on pathology samples is required to ensure sample adequacy. A second TURBT is recommended but not required for patients with T1 tumours. The use of either white-light cystoscopy or blue-light cystoscopy is permitted, but the same technique has to be used in a patient throughout the trial
Evidence of upper urinary tract carcinoma
Hydronephrosis due to tumour in the presence of T1 disease
Patients on current systemic therapy for bladder cancer
Patients who have received pelvic external beam radiotherapy within the previous 5 years
Single group
radiation therapy
RadiationRadiation therapy will be given in 20 fractions of 2.75 Gy covering the whole bladder over 4 weeks. The use of a radiosensitizing agent is mandatory. Each recruiting center will have to choose 2 options of radiosensitizing agents.
Proportion of patients with a complete response at 6 months post-radiotherapy
Progression-free survival
overall survival
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