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

Primary Purpose

Urothelial Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Docetaxel
Placebo Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urothelial Carcinoma focused on measuring Intravesical Chemotherapy, Docetaxel, Radical Nephroureterectomy

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Docetaxel bladder instillation arm

Control arm

Arm Description

After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)

After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)

Outcomes

Primary Outcome Measures

Recurrence in bladder
Present of bladder recurrence after intervention in follow up cystoscopy or CT scan

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2017
Last Updated
December 21, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03209206
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
June 19, 2020 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
Keywords
Intravesical Chemotherapy, Docetaxel, Radical Nephroureterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Phase II Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel bladder instillation arm
Arm Type
Experimental
Arm Description
After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Instillation docetaxel after radical nephroureterectomy
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo Normal saline
Other Intervention Name(s)
Instillation Normal saline after radical nephroureterectomy
Intervention Description
Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
Primary Outcome Measure Information:
Title
Recurrence in bladder
Description
Present of bladder recurrence after intervention in follow up cystoscopy or CT scan
Time Frame
2years
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Present of adverse event after intervention
Time Frame
2years
Title
Overall Survival
Description
Overall Survival rate during follow up period
Time Frame
2years
Title
Time to recurrence
Description
Time to bladder recurrence after intervention in follow up cystoscopy or CT scan
Time Frame
2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ja Hyeon Ku, M.D.,PH.D
Phone
+82-2-2072-0361
Email
randyku@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Bum Sik Tae, M.D
Phone
+82-10-9056-6618
Email
bumsik4ever@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ja Hyeon Ku, M.D.,PH.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ja Hyeon Ku, M.D, Ph.D
Phone
82-2-2072-0361
Email
randyku@hanmail.net
First Name & Middle Initial & Last Name & Degree
Bum Sik Tae, M.D
Phone
82-2-2072-0361
Email
bumsik4ever@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23460707
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.
Results Reference
result
PubMed Identifier
23563166
Citation
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.
Results Reference
result
PubMed Identifier
26537069
Citation
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.
Results Reference
result
PubMed Identifier
19913890
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.
Results Reference
result
PubMed Identifier
25772330
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.
Results Reference
result
PubMed Identifier
19389012
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.
Results Reference
result

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

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