Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study

Standard treatment for patients with high-risk NMIBC (high-grade Ta, CIS, or any T1) consists of intravesical Bacillus Calmette-Guerin (BCG) immunotherapy. However, BCG, even administered optimally, does not provide absolute protection and BCG failure is generally considered recurrence or progression during therapy. Patients who are BCG-unresponsive have a 20-40% risk for progression to muscle-invasive bladder cancer within 5 years, and a 50% risk of developing metastatic disease. For these patients, radical cystectomy with pelvic lymph node dissection and urinary diversion is the standard of

Trial Details

NCT ID
NCT06990061
Phase
NA
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Radiation therapy
Locations (sample)
  • Anderlecht, Brussels Capital, Belgium|50.83619,4.31454
  • Brussels, Belgium|50.85045,4.34878
  • Wilrijk, Belgium|51.16734,4.39513

Key Eligibility Criteria

  • Histologically confirmed, BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (according to EAU guidelines \[2\] (see table 1)) °of pred…
  • Patients with carcinoma in situ with or without high-grade Ta or T1 are allowed if patients with concomitant Ta and T1 tumors have undergone comple…
  • The most recent cystoscopy or TURBT must have been done within 12 weeks before study enrolment.
  • Eastern Cooperative Oncology Group performance status of 0-2

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Muscle-Invasive Bladder Cancer Trials on Trialify →