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

Phase 2UnknownNCT03209206

Seoul National University Hospital84 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Urothelial Carcinoma

Interventions

DocetaxelDRUG

Intravesical Instillation of Docetaxel (Docetaxel 75 mg diluted in 100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)

Placebo Normal salineDRUG

Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Recurrence in bladder

Present of bladder recurrence after intervention in follow up cystoscopy or CT scan

Time frame: 2years

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events

Present of adverse event after intervention

Time frame: 2years

Overall Survival

Overall Survival rate during follow up period

Time frame: 2years

Time to recurrence

Time to bladder recurrence after intervention in follow up cystoscopy or CT scan

Time frame: 2years

Central Contacts

Ja Hyeon Ku, M.D.,PH.D

CONTACT

+82-2-2072-0361 randyku@hanmail.net

Bum Sik Tae, M.D

CONTACT

+82-10-9056-6618 bumsik4ever@hanmail.net

Data from ClinicalTrials.gov

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