Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation

Sponsor
Ankara Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05084586
Collaborator
(none)
100
1
2
37
2.7

Study Details

Study Description

Brief Summary

In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravesical Solution
  • Drug: Intravesical Solution
N/A

Detailed Description

Bladder cancer (BC) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. Worldwide, the BC age-standardised mortality rate (per 100,000 person/years) was 3.3 for men vs. 0.86 for women.It is more common, especially in developed countries. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer).

Epirubicin is an anthracycline drug used for chemotherapy. Immediate single instillation of epirubicin has been shown to act by destroying circulating tumour cells after TURB(Transurethral Resection of a Bladder Tumor), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours.European Association of Urology Guidelines on Bladder Cancer advocates single immediate postoperative intravesical chemotherapy. Early single-dose instillation of epirubicin immediately after transurethral resection was shown to improve recurrence rates in low and intermediate risk groups.

Immediate single instillation of epirubicin into the bladder can induce an array of irritative voiding symptoms including dysuria, frequency, urgency, suprapubic discomfort, hematuria and pelvic pain. In some cases, patients cannot tolerate these symptoms and may necessitate removal of chemotherapeutic agent for alleviation. Incomplete instillation leads to an increase in recurrence and progression rates. In this study, continuous infusion of epirubicin into the bladder and instillation of a single dose epirubicin will be evaluated in terms of side effects, tumor recurrence and progression rates.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Continuous Intravesical Infusion of Epirubicin

Patients who received continuous epirubicin infusion into the bladder in the early postoperative period.

Drug: Intravesical Solution
After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 150 ml saline was continuously instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.
Other Names:
  • Continuous Epirubicin Instillation During the Early Postoperative Period
  • Sham Comparator: Single-Dose Instillation of Epirubicin

    Patients who received single-dose epirubicin into the bladder in the early postoperative period.

    Drug: Intravesical Solution
    After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 50 ml saline was instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.
    Other Names:
  • Single-Dose Epirubicin Instillation During the Early Postoperative Period
  • Outcome Measures

    Primary Outcome Measures

    1. Rate of Tumor Recurrence and Progression [1 year]

      Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Low and intermediate risk NMIBC
    Exclusion Criteria:
    • High risk NMIBC

    • Patients who received intravesical BCG

    • Postoperative gross hematuria

    • Bladder perforation

    • Pregnancy

    • Urinary tract infection

    • Epirubicin allergy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara Training and Research Hospital Ankara Altindag Turkey 06230

    Sponsors and Collaborators

    • Ankara Training and Research Hospital

    Investigators

    • Principal Investigator: Ali Kaan Yildiz, Ankara Training and Resarch Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ali Kaan Yildiz, Principal Investigator, Ankara Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05084586
    Other Study ID Numbers:
    • BC2021EPI
    First Posted:
    Oct 20, 2021
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ali Kaan Yildiz, Principal Investigator, Ankara Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022