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Clinical Trials/NCT05084586
NCT05084586RecruitingNot Applicable

Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer

Ankara Training and Research Hospital1 site in 1 country100 target enrollmentStarted: October 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Rate of Tumor Recurrence and Progression

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Continuous Intravesical Infusion of Epirubicin

Active Comparator

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

Intervention: Intravesical Solution (Drug)

Single-Dose Instillation of Epirubicin

Sham Comparator

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

Intervention: Intravesical Solution (Drug)

Outcomes

Primary Outcomes

Rate of Tumor Recurrence and Progression

Time Frame: 1 year

Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ankara Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Kaan Yildiz

Principal Investigator

Ankara Training and Research Hospital

Study Sites (1)

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