Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-07
Brief Title:
HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer
Sponsor:
Affiliated Cancer Hospital Institute of Guangzhou Medical University
Organization:
Affiliated Cancer Hospital Institute of Guangzhou Medical University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 3g150ml 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None