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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Effectiveness and Safety of Intravesical Docetaxel Instillation After Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy or Distal Ureterectomy in Upper Urinary Tract Urothelial Carcinoma: A Prospective Study

Conditions
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Urothelial Carcinoma

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Placebo Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Phase II Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel bladder instillation arm<br>After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline) | Drug: Docetaxel<br>* 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)<br>* Other names: Instillation docetaxel after radical nephroureterectomy;|
| Placebo Comparator: Control arm<br>After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline) | Drug: Placebo Normal saline<br>* Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)<br>* Other names: Instillation Normal saline after radical nephroureterectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence in bladder | Present of bladder recurrence after intervention in follow up cystoscopy or CT scan | 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Present of adverse event after intervention | 2years | 
| Overall Survival | Overall Survival rate during follow up period | 2years | 
| Time to recurrence | Time to bladder recurrence after intervention in follow up cystoscopy or CT scan | 2years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravesical Chemotherapy, Docetaxel, Radical Nephroureterectomy