The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence
December 21, 2017 updated by: Ja Hyeon Ku, Seoul National University Hospital
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
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Recruiting
- Seoul National University Hospital
-
Contact:
- Ja Hyeon Ku, M.D, Ph.D
- Phone Number: 82-2-2072-0361
- Email: randyku@hanmail.net
-
Contact:
- Bum Sik Tae, M.D
- Phone Number: 82-2-2072-0361
- Email: bumsik4ever@hanmail.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Docetaxel bladder instillation arm
After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)
|
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)
Other Names:
|
|
Placebo Comparator: Control arm
After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence in bladder
Time Frame: 2years
|
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
Time Frame: 2years
|
Present of adverse event after intervention
|
2years
|
|
Overall Survival
Time Frame: 2years
|
Overall Survival rate during follow up period
|
2years
|
|
Time to recurrence
Time Frame: 2years
|
Time to bladder recurrence after intervention in follow up cystoscopy or CT scan
|
2years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ja Hyeon Ku, M.D.,PH.D, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2017
Primary Completion (Anticipated)
June 19, 2020
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
June 30, 2017
First Submitted That Met QC Criteria
July 3, 2017
First Posted (Actual)
July 6, 2017
Study Record Updates
Last Update Posted (Actual)
December 22, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Carcinoma
- Recurrence
- Carcinoma, Transitional Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- SeoulNUHUro
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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