The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence
NCT ID: NCT03209206
Last Updated: 2017-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
84 participants
INTERVENTIONAL
2017-06-28
2022-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Docetaxel bladder instillation arm
After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)
Docetaxel
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)
Control arm
After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)
Placebo Normal saline
Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
Interventions
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Docetaxel
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 saline
Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
85 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ja Hyeon Ku
Professor, MD., PHD.
Principal Investigators
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Ja Hyeon Ku, M.D.,PH.D
Role: STUDY_DIRECTOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Ja Hyeon Ku, M.D, Ph.D
Role: primary
Bum Sik Tae, M.D
Role: backup
References
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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.
Delto JC, Kobayashi T, Benson M, McKiernan J, Abate-Shen C. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer progression. Oncotarget. 2013 Feb;4(2):269-76. doi: 10.18632/oncotarget.852.
Wu P, Zhu G, Wei D, Liu S, Walsh K, Li D, Harron U, Wang X, Ma H, Wan B, Sun L, Yang Z, Wang J. Prophylactic intravesical chemotherapy decreases bladder tumor recurrence after nephroureterectomy for primary upper tract urothelial carcinoma: A systematic review and meta-analysis. J BUON. 2015 Sep-Oct;20(5):1229-38.
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.
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.
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.
Other Identifiers
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SeoulNUHUro
Identifier Type: -
Identifier Source: org_study_id