Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer (NCT06310369) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer
50 participantsStarted 2025-03-01
Plain-language summary
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.
Who can participate
Age range18 Years ā 100 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Definition of BCG unresponsive non-muscle-invasive bladder cancer according to the European Association of Urology (EAU) guidelines
Exclusion Criteria:
* 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
What they're measuring
1
Proportion of patients with a complete response at 6 months post-radiotherapy
Timeframe: 6 months post-radiotherapy
Trial details
NCT IDNCT06310369
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC