Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-100
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • radiation therapy

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations