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Carcinoma of Urinary Bladder, Superficial |

Carcinoma of Urinary Bladder, Superficial research study

What is the primary objective of this study?

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).

Who is eligible to participate?

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Carcinoma of Urinary Bladder, Superficial

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:EpirubicinExperimental: 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study group(Epirubicin)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

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

Study Status

Completed

Start Date: July 2014

Completed Date: May 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Recurrence, progression and/or death from cancer.

Secondary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Study sponsors, principal investigator, and references

Principal Investigator: Bedeir A El-Dein, Professor

Lead Sponsor: Mansoura University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02214602

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