Carcinoma of Urinary Bladder, Superficial Clinical Trial
— NMIBCIVTOfficial title:
The Value of Immediate Post-operative Intravesical Epirubicin Instillation in Intermediate and High Risk Non Muscle Invasive Bladder Cancer (NMIBC): A Randomized Controlled Trial
Verified date | March 2018 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 240 |
Est. completion date | May 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence, progression and/or death from cancer. | within the 1st year after complete Transurethral resection of bladder tumor | ||
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | within 1st 24 hours following intravesical instillation of the used drug |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Combined Use of BCG and Interferon Alpha in Bladder Cancer
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Phase 2/Phase 3 | |
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N/A |