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

NCT ID: NCT05084586

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-11-05

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous Intravesical Infusion of Epirubicin

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

Group Type: ACTIVE_COMPARATOR

Intravesical Solution

Intervention Type: DRUG

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.

Single-Dose Instillation of Epirubicin

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

Group Type: SHAM_COMPARATOR

Intravesical Solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Continuous Epirubicin Instillation During the Early Postoperative Period; Single-Dose Epirubicin Instillation During the Early Postoperative Period

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ali Kaan Yildiz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Kaan Yildiz

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Resarch Hospital

Locations

Ankara Training and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ali Kaan Yildiz

Role: CONTACT

alikaanyildiz@gmail.com

+90 554 773 16 96

Arif Bedirhan Bayraktar

Role: CONTACT

arifbdrhn@gmail.com

+90 555 850 99 28

Facility Contacts

Ali Kaan Yildiz

Role: primary

alikaanyildiz@gmail.com

+90 554 773 16 96

References

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.

Reference Type: BACKGROUND

PMID: 18609290 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10876750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16188156 (View on PubMed)

Other Identifiers

BC2021EPI

Identifier Type: -

Identifier Source: org_study_id