Urothelial Carcinoma
Conditions
Keywords
Intravesical Chemotherapy, Docetaxel, Radical Nephroureterectomy
Brief 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).
Detailed 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.
Interventions
DRUGDocetaxel
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)
Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective Randomized Phase II Trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence in bladder | 2years | Present of bladder recurrence after intervention in follow up cystoscopy or CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 2years | Present of adverse event after intervention |
| Overall Survival | 2years | Overall Survival rate during follow up period |
| Time to recurrence | 2years | Time to bladder recurrence after intervention in follow up cystoscopy or CT scan |
Countries
South Korea
Contacts
Primary ContactJa Hyeon Ku, M.D.,PH.D
Backup ContactBum Sik Tae, M.D
Outcome results
None listed