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HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

Non-Muscle-Invasive Bladder Cancer Clinical Trial

Official title:
A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intravesical Chemotherapy After Transurethral Resection of Bladder Tumors in Patients With Non-Muscle-Invasive Bladder Cancer

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).

Clinical Trial Description

In this study, patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) and planed to undergo Transurethral Resection of Bladder Tumors (TURBT) are randomized into HIVEC group and control group. In HIVEC group, HIVEC is performed with Gemcitabine Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes within 4 weeks, once a week (±5 days) for 6 to 8 times, once a month to 1 year. For the patients in the control group, Intravesical Chemotherapy is administered after TURBT. The primary endpoint is 2-year recurrence rate. Secondary end points include 1-year recurrence rate, recurrence-free survival (RFS) rate, disease free survival (DFS) rate, time to treatment failure (TTF), Success rate of therapeutic operation, Instrument performance evaluation, quality of international prostate symptom score, quality of Urinary Symptoms Distress Score. All efficacy analyses are conducted in the intention-to-treat population. Safety analysis include only patients who receive their randomly assigned treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06327932
Study type Interventional
Source Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Contact Shuzhong Cui, MD
Phone 020-66673666
Email cuishuzhong@gzhmu.edu
Status Not yet recruiting
Phase Phase 3
Start date April 1, 2024
Completion date March 31, 2028
View Details
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