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

Primary Purpose

Bladder Cancer, Epirubicin Adverse Reaction, Superficial Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intravesical Solution
Intravesical Solution
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Non-Muscle Invasive Bladder Cancer, Epirubicin, Intravesical Chemotherapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ankara Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Continuous Intravesical Infusion of Epirubicin

Single-Dose Instillation of Epirubicin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of Tumor Recurrence and Progression
Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment

Secondary Outcome Measures

Full Information

First Posted
September 2, 2021
Last Updated
March 25, 2023
Sponsor
Ankara Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05084586
Brief Title
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation
Official Title
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
November 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Epirubicin Adverse Reaction, Superficial Bladder Cancer, Tumor Recurrence
Keywords
Non-Muscle Invasive Bladder Cancer, Epirubicin, Intravesical Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Intravesical Infusion of Epirubicin
Arm Type
Active Comparator
Arm Description
Patients who received continuous epirubicin infusion into the bladder in the early postoperative period.
Arm Title
Single-Dose Instillation of Epirubicin
Arm Type
Sham Comparator
Arm Description
Patients who received single-dose epirubicin into the bladder in the early postoperative period.
Intervention Type
Drug
Intervention Name(s)
Intravesical Solution
Other Intervention Name(s)
Continuous Epirubicin Instillation During the Early Postoperative Period
Intervention Description
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
Intervention Name(s)
Intravesical Solution
Other Intervention Name(s)
Single-Dose Epirubicin Instillation During the Early Postoperative Period
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Tumor Recurrence and Progression
Description
Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Kaan Yildiz
Phone
+90 554 773 16 96
Email
alikaanyildiz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arif Bedirhan Bayraktar
Phone
+90 555 850 99 28
Email
arifbdrhn@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Kaan Yildiz
Organizational Affiliation
Ankara Training and Resarch Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Kaan Yildiz
Phone
+90 554 773 16 96
Email
alikaanyildiz@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
18609290
Citation
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.
Results Reference
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PubMed Identifier
10876750
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.
Results Reference
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PubMed Identifier
16188156
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.
Results Reference
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Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation

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