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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Superficial Bladder Cancer; Tumor Recurrence; Epirubicin Adverse Reaction
• Intervention / Treatment: Drug: Intravesical Solution; Drug: Intravesical Solution

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arif Bedirhan Bayraktar; Phone Number: +90 555 850 99 28; Email: arifbdrhn@gmail.com

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey, 06230
      • Recruiting
      • Ankara Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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
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 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Tumor Recurrence and Progression	Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment	1 year

Collaborators and Investigators

• Sponsor: Ankara Training and Research Hospital

Publications and helpful links

General Publications

• Engeler DS, Wyler S, Neyer M, Hobi C, Muller J, Schmid HP. Feasibility of early intravesical instillation chemotherapy after transurethral resection of the bladder: a prospective evaluation in a consecutive series of 210 cases. Scand J Urol Nephrol. 2008;42(6):522-7. doi: 10.1080/00365590802133099.
• Maekawa S, Suzuki H, Ohkubo K, Aoki Y, Okada T, Maeda H, Ogura K, Arai Y. [Continuous intravesical instillation of epirubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study]. Hinyokika Kiyo. 2000 May;46(5):301-6. Japanese.
• Wu ZB, Lin GB, Chen BJ, Wu ZM, Rong RM. [Efficacy and safety of different dosages of intravesical epirubicin instillation for prevention of primary superficial bladder carcinoma from recurrence]. Zhonghua Zhong Liu Za Zhi. 2005 Aug;27(8):507-9. Chinese.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): October 5, 2023
• Study Completion (Anticipated): November 5, 2023

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Epirubicin; Non-Muscle Invasive Bladder Cancer; Intravesical Chemotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Disease Attributes; Recurrence; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Epirubicin; Pharmaceutical Solutions
• Other Study ID Numbers: BC2021EPI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No