NCT05084586

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

September 2, 2021

Last Update Submit

March 25, 2023

Conditions

Bladder CancerEpirubicin Adverse ReactionSuperficial Bladder CancerTumor Recurrence

Keywords

Non-Muscle Invasive Bladder CancerEpirubicinIntravesical Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Rate of Tumor Recurrence and Progression

    Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment

    1 year

Study Arms (2)

Continuous Intravesical Infusion of Epirubicin

ACTIVE COMPARATOR

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

Drug: Intravesical Solution

Single-Dose Instillation of Epirubicin

SHAM COMPARATOR

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

Drug: Intravesical Solution

Interventions

Intravesical SolutionDRUG

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.

Also known as: Continuous Epirubicin Instillation During the Early Postoperative Period
Continuous Intravesical Infusion of Epirubicin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low and intermediate risk NMIBC

You may not qualify if:

  • High risk NMIBC
  • Patients who received intravesical BCG
  • Postoperative gross hematuria
  • Bladder perforation
  • Pregnancy
  • Urinary tract infection
  • Epirubicin allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 18609290BACKGROUND

  • 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.

    PMID: 10876750BACKGROUND

  • 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.

    PMID: 16188156BACKGROUND

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Kaan Yildiz

    Ankara Training and Resarch Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Kaan Yildiz

CONTACT

+90 554 773 16 96alikaanyildiz@gmail.com

Arif Bedirhan Bayraktar

CONTACT

+90 555 850 99 28arifbdrhn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2021

First Posted

October 20, 2021

Study Start

October 1, 2019

Primary Completion

October 5, 2023

Study Completion

November 5, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

TU(1)