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

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)
Drug: 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)
Other Names:
  • Instillation docetaxel after radical nephroureterectomy
Placebo Comparator: Control arm
After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)
Drug: 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 Names:
  • Instillation Normal saline after radical nephroureterectomy

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.

Sponsor

Seoul National University Hospital

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

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

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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