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

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ClinicalTrials.gov Identifier: NCT03209206
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Ja Hyeon Ku, Seoul National University Hospital

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).

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Docetaxel Drug: Placebo Normal saline Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized Phase II Trial
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

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 Name: 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 Name: Instillation Normal saline after radical nephroureterectomy




Primary Outcome Measures :
  1. Recurrence in bladder [ Time Frame: 2years ]
    Present of bladder recurrence after intervention in follow up cystoscopy or CT scan


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2years ]
    Present of adverse event after intervention

  2. Overall Survival [ Time Frame: 2years ]
    Overall Survival rate during follow up period

  3. Time to recurrence [ Time Frame: 2years ]
    Time to bladder recurrence after intervention in follow up cystoscopy or CT scan



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209206


Contacts
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Contact: Ja Hyeon Ku, M.D.,PH.D +82-2-2072-0361 randyku@hanmail.net
Contact: Bum Sik Tae, M.D +82-10-9056-6618 bumsik4ever@hanmail.net

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Ja Hyeon Ku, M.D, Ph.D    82-2-2072-0361    randyku@hanmail.net   
Contact: Bum Sik Tae, M.D    82-2-2072-0361    bumsik4ever@hanmail.net   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Ja Hyeon Ku, M.D.,PH.D Seoul National University Hospital

Publications of Results:

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Responsible Party: Ja Hyeon Ku, Professor, MD., PHD., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03209206     History of Changes
Other Study ID Numbers: SeoulNUHUro
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ja Hyeon Ku, Seoul National University Hospital:
Intravesical Chemotherapy
Docetaxel
Radical Nephroureterectomy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action