NCT02214602

Brief Summary

The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

2.8 years

First QC Date

July 10, 2014

Last Update Submit

March 21, 2018

Conditions

Carcinoma of Urinary Bladder, Superficial

Keywords

non muscle invasive bladder cancerintermediate and high riskimmediate single instillationIntravesical chemotherapyDisease prevention

Outcome Measures

Primary Outcomes (1)

  • Recurrence, progression and/or death from cancer.

    within the 1st year after complete Transurethral resection of bladder tumor

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    within 1st 24 hours following intravesical instillation of the used drug

Study Arms (2)

Study group(Epirubicin)

EXPERIMENTAL

in this arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor

Drug: Epirubicin

Control group

NO INTERVENTION

in this arm -control group- : patients will not receive immediate intravesical instillation of of epirubicin after compete transurethral resection of bladder tumor.

Interventions

EpirubicinDRUG

Experimental: Study group(Epirubicin) in the arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor

Also known as: Intravesical chemotherapy, Doxorubicin
Study group(Epirubicin)

Eligibility Criteria

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

You may qualify if:

  • Ability to give informed consent.
  • Patients with primary or recurrent papillary Non muscle invasive bladder cancer (NMIBC).
  • Complete transurethral resection of bladder tumor(TURBT).
  • Normal cardiac, hematological, and renal functions.
  • Patients with intermediate and high risk NMIBC confirmed by histopathology.

You may not qualify if:

  • Inability to give informed consent.
  • Patients with history of previous radiotherapy or systemic chemotherapy.
  • Patients suffering from immuno-deficiency or other malignancies.
  • Patients with history of hypersensitivity reaction to epirubicin.
  • Examination under anesthesia (EUA) reveals palpable bladder mass.
  • Patients with primary, single, less than 1cm papillary bladder tumor (high likelihood of being low risk).
  • Suspicion of perforation of the bladder during TURBT.
  • Patients who develop hematuria in the recovery room necessitating continuous bladder wash or endoscopic haemostasis.
  • Patients with proven low risk NMIBC on histopathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

  • Elsawy AA, El-Assmy AM, Bazeed MA, Ali-El-Dein B. The value of immediate postoperative intravesical epirubicin instillation as an adjunct to standard adjuvant treatment in intermediate and high-risk non-muscle-invasive bladder cancer: A preliminary results of randomized controlled trial. Urol Oncol. 2019 Mar;37(3):179.e9-179.e18. doi: 10.1016/j.urolonc.2018.10.019. Epub 2018 Nov 14.

    PMID: 30448030DERIVED

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

EpirubicinDoxorubicin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Bedeir A El-Dein, Professor

    Urology And Nephrology Center, Mansoura University, Mansoura

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Study Record Dates

First Submitted

July 10, 2014

First Posted

August 12, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

EG(1)