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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084586
• Other study ID #: BC2021EPI
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 5, 2023

Study information

• Verified date: March 2023
• Source: Ankara Training and Research Hospital
• Contact: Ali Kaan Yildiz
• Phone: +90 554 773 16 96
• Email: alikaanyildiz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Superficial Bladder Cancer
• Tumor Recurrence
• Urinary Bladder Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Tumor Recurrence and Progression	Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment	1 year