Carcinoma of Urinary Bladder, Superficial Clinical Trial
Official 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
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).
Preoperative evaluation will be carried out in the form of routine laboratory investigations,
abdominal and pelvic US and computed tomography (CT) or magnetic resonance imaging (MRI)
abdomen and pelvis if necessary. Then, the patients will be subjected to complete TURBT.
The patients will be transferred to the recovery room, careful monitoring of the patients
will be carried out for the 1st 30 min, and then after confirming the patient eligibility for
enrollment in the study by exclusion of cases with hematuria and suspicious bladder
perforation, patients will be enrolled randomly into one of the two groups. The randomization
process will be performed using computer-generated simple random tables in a 1:1 ratio or by
the method of closed envelopes.
The 1st group will not receive intravesical instillation of epirubicin -Placebo-(control
group), and, the 2nd group will receive intravesical instillation of epirubicin 50 mg in 50
ml saline 0.9% (study group) with clamping of the urethral catheter for 1 hour after
instillation and during this period the patients are monitored for local or systemic adverse
events (acute abdomen, chills, fever, hot flushes, abdominal rigidity, hematuria after
de-clamping of the catheter).
Evaluation:
Intraoperative and early postoperative parameters of interest will be recorded and compared
between the two groups like EUA findings, tumor characteristics during cystoscopy as the
tumor size, site, shape, number, suspicion of CIS, post instillation adverse events, cytology
and biopsy results.
The patients will be discharged after removal of urethral catheter. They will be stratified
into either intermediate or high risk histopathologically confirmed NMIBC, followed up at the
outpatient clinic (OPC) and will receive adjuvant intravesical instillation of chemotherapy
or immunotherapy according to the European Association of Urology (EAU) guidelines for each
risk group. The patients will be evaluated by office cystoscopy and urine cytology at the OPC
after 12 weeks, and thereafter every 3 months during the first 2 years and then every 3 to 6
months according to the risk category.
During the follow-up period, all histopathologically confirmed tumors will be classified as
recurrences. Time to first recurrence will be the primary end point of the study, and the
length of follow-up will be defined as the time from inclusion to the last cystoscopy
control.
Methods of evaluation and follow-up:
All the patients will be evaluated on entry and at follow-up intervals. On study entry
patients will be evaluated by urinalysis, urine culture, serum creatinine, fasting blood
sugar level, complete blood count, chest X-ray, excretory urography (IVU) and or CT urography
and bladder wash for cytology. CT with contrast will be performed annually in cases of high
risk tumor category and when otherwise indicated. Complete TURBT of all visible tumors will
be conducted in all patients and the stage and grade will be determined according to the 1987
staging classification and World Health Organization (WHO) grading system in 1973+ 2004 WHO
grading system.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00330707 -
Combined Use of BCG and Interferon Alpha in Bladder Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT01803295 -
Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC
|
N/A |