Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence

What this Trial Is About

Researchers are studying patients suspected of having upper tract urothelial carcinoma (UTUC) to evaluate the safety and cancer-related outcomes of a single chemotherapy bladder instillation after endoscopic treatment. The study aims to determine if this single chemotherapy dose given after ureteroscopy (URS) can reduce the chance of bladder cancer recurrence inside the bladder, known as intravesical recurrence (IVR). Participants will receive a single bladder instillation of chemotherapy, either Mitomycin or Gemcitabine, within 24 hours after URS. Some participants will receive the chemotherapy instillation while others will receive a placebo instillation of saline. The study uses a randomized design with single masking to compare the effects of the chemotherapy against saline. Patients will undergo routine follow-up including white light cystoscopy, and those with suspected bladder recurrence will receive further treatment such as transurethral resection of bladder tumor (TURBT). During the study, participants will be monitored for recurrence of bladder cancer over one and two years, measuring IVR-free survival and disease-free survival as main outcomes. Adverse events of grade 3 or higher will also be tracked over two years. The study involves regular cystoscopy and imaging to detect any bladder recurrence. Participants will be followed for up to two years after treatment to assess the long-term effects and safety of the chemotherapy instillation.

POST URS Chemotherapy Instillation