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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Urothelial Carcinoma

Treatments: Drug: Docetaxel; Drug: Placebo Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03209206

SeoulNUHUro

Details and patient eligibility

About

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).

Full description

Approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (UUT-UC) experience bladder recurrence after nephroureterectomy. Although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. A meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (TURBT) significantly decreased the risk of recurrence in patients with bladder cancer. Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer.

In this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of Docetaxel in the prevention of bladder recurrence after nephroureterectomy for UUT-UC.

Enrollment: 84 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups, including a placebo group

Docetaxel bladder instillation arm

Experimental group

Description:

After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)

Treatment:

Drug: Docetaxel

Control arm

Placebo Comparator group

Description:

After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)

Treatment:

Drug: Placebo Normal saline