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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03209206
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
57.1
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective Randomized Phase II TrialProspective 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 :
Jun 28, 2017
Anticipated Primary Completion Date :
Jun 19, 2020
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence in bladder [2years]

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

    Secondary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [2years]

      Present of adverse event after intervention

    2. Overall Survival [2years]

      Overall Survival rate during follow up period

    3. Time to recurrence [2years]

      Time to bladder recurrence after intervention in follow up cystoscopy or CT scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Study Director: Ja Hyeon Ku, M.D.,PH.D, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ja Hyeon Ku, Professor, MD., PHD., Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03209206
    Other Study ID Numbers:
    • SeoulNUHUro
    First Posted:
    Jul 6, 2017
    Last Update Posted:
    Dec 22, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Professor, MD., PHD., Seoul National University Hospital
    Intravesical Chemotherapy
    Docetaxel
    Radical Nephroureterectomy
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Transitional Cell
    Recurrence
    Docetaxel

    Study Results

    No Results Posted as of Dec 22, 2017