Clinical trial · Interventional
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
NCT06310369CI-TRIAL-00079011not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy arm
- description
- Radiation therapy will be given covering the whole bladder over 4 weeks. The use of a radiosensitizing agent is mandatory.
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Proportion of patients with a complete response at 6 months post-radiotherapy
- timeFrame
- 6 months post-radiotherapy
Secondary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- 5 years from randomisation
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.