The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Upper urinary tract urothelial cell carcinoma

• Hb>10g/dL, ANC >1500mm3, Platelet > 100K

• Total bilirubin : 1.5 times lower than the normal upper limit

• AST/ALT: 1.8 times lower than the normal upper limit

• Alkaline phosphatase: 1.8 times lower than the normal upper limit

Exclusion Criteria:

• Concomitant bladder tumor

• Patients diagnosed with bladder cancer within the last 3 years

• Previous history of hypersensitivity to Docetaxel

• Neurogenic Bladder

• Patients who received chemotherapy for cancer within the last 6 months

• Patients with active disease not fit for this study

• ANC <1500mm3

• Pregnant or lactating women

• Patients with severe hepatic dysfunction

• patients with severe renal impairment

• patients with hypersensitivity to mannitol, paraplatin, platinum compounds

• Patients with complications of infection

• Patients suspected of having infectious fever