Clinical trial NCT03209206: The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urothelial Carcinoma
Keywords: Intravesical Chemotherapy
Docetaxel
Radical Nephroureterectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Phase II Trial
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Recurrence in bladder
timeFrame: 2years
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 2years
measure: Overall Survival
timeFrame: 2years
measure: Time to recurrence
timeFrame: 2years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ja Hyeon Ku, M.D.,PH.D
role: STUDY_DIRECTOR
References:
citation: Ito A, Shintaku I, Satoh M, Ioritani N, Aizawa M, Tochigi T, Kawamura S, Aoki H, Numata I, Takeda A, Namiki S, Namima T, Ikeda Y, Kambe K, Kyan A, Ueno S, Orikasa K, Katoh S, Adachi H, Tokuyama S, Ishidoya S, Yamaguchi T, Arai Y. Prospective randomized phase II trial of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma: the THP Monotherapy Study Group Trial. J Clin Oncol. 2013 Apr 10;31(11):1422-7. doi: 10.1200/JCO.2012.45.2128. Epub 2013 Mar 4.
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citation: Laudano MA, Barlow LJ, Murphy AM, Petrylak DP, Desai M, Benson MC, McKiernan JM. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. Urology. 2010 Jan;75(1):134-7. doi: 10.1016/j.urology.2009.06.112. Epub 2009 Nov 13.
citation: Lu S, Neoh KG, Kang ET, Mahendran R, Chiong E. Mucoadhesive polyacrylamide nanogel as a potential hydrophobic drug carrier for intravesical bladder cancer therapy. Eur J Pharm Sci. 2015 May 25;72:57-68. doi: 10.1016/j.ejps.2015.03.006. Epub 2015 Mar 13.
citation: Barlow L, McKiernan J, Sawczuk I, Benson M. A single-institution experience with induction and maintenance intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to bacille Calmette-Guerin therapy. BJU Int. 2009 Oct;104(8):1098-102. doi: 10.1111/j.1464-410X.2009.08543.x. Epub 2009 Apr 15.