NCT06310369Not yet recruitingPhase 2
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicenter, Phase 2 Study
Source: ClinicalTrials.gov · Last updated 22 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 1 Mar 2025
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Diseases
- Bladder cancer
- NCT number
- NCT06310369
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Mar 2025 to the primary completion date, 1 Oct 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received pelvic external beam radiotherapy within the previous 5 years
Other illness
- Hydronephrosis due to tumour in the presence of T1 disease
- Patients on current systemic therapy for bladder cancer
Other
- Evidence of upper urinary tract carcinoma
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.