Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02716961
Status:
UNKNOWN
Last Update Posted:
2016-03-24
First Post:
2016-03-14
Brief Title:
Transurethral Resection of Bladder Tumor TURBT Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Prospective Cohort Study of Transurethral Resection of Bladder Tumor TURBT Combined With Adjuvant Intravenous GC Chemotherapy to Prevent Moderate-high Recurrence and Progression Risks of Muscle-invasive Bladder Cancer
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
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:
It is still a challenge for urologic surgeon to prevent the post transurethral resection of bladder tumor TURBT recurrence of moderate-high risk non-muscle invasive bladder tumor Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor which contains mainstream GC treatment scheme It is common to observe clinically moderate-high risk NMIBC recurrence after routine intravesical instillationSystematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC
Detailed Description:
Prevention of the post-transurethral resection of bladder tumor TURBT recurrence of moderate-high risk non-muscle invasive bladder cancerNMIBC is still a difficult problem NMIBC was classified as low moderate and high risk patients Moderate-high risk NMIBC contained those are multiple recurrent II-III grade tumor diameter 3cm invasive to submucosa and associated with carcinoma in situ For those patients no matter which treatment was conducted for example exchanging instillation drugs increasing medicine dose appending adjuvant drugs and prolonging instillation time would not improve the prognosis of these patients Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor which contains mainstream GC treatment scheme For muscle invasive bladder cancer patients radical cystectomy with neoadjuvant chemotherapy will improve patients tumor grade and increase overall survival and disease specific survival rateSystematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC In addition we also would like to investigate the improvement of life quality after TURBT of moderate-high risk NMIBC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None