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

Ankara Training and Research Hospital

Status: Enrolling

Conditions: Epirubicin Adverse Reaction; Superficial Bladder Cancer; Bladder Cancer; Tumor Recurrence

Treatments: Drug: Intravesical Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05084586

BC2021EPI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Continuous Intravesical Infusion of Epirubicin

Active Comparator group

Description:

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

Treatment:

Drug: Intravesical Solution

Drug: Intravesical Solution

Single-Dose Instillation of Epirubicin

Sham Comparator group

Description:

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

Treatment:

Drug: Intravesical Solution

Drug: Intravesical Solution