Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05503563
Status:
UNKNOWN
Last Update Posted:
2022-08-16
First Post:
2022-07-29
Brief Title:
A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder
Status:
UNKNOWN
Status Verified Date:
2022-08
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:
In Egypt bladder cancer has been the most common cancer during the past 50 years In 2002 Egypts world-standardized bladder cancer incidence was 37 100000 representing approximately 30000 new cases each year
About 25 of new diagnoses are muscle-invasive bladder cancer MIBC which carry a worse prognosis compared to non-muscle invasive disease
Neoadjuvant chemotherapy NAC followed by radical cystectomy RC with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of MIBC by multiple international guidelines
However this is associated with a significant impact on quality of life
The effect of our proposed Tetra-modal treatment protocol for muscle invasive Urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival cancer specific survival and overall survival
Koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor induction chemoradiation CRT and consolidative partial cystectomy PC with pelvic lymph node dissection allowing the confirmation of CRT response pathologically In the preliminary analysis of the initial cases enrolled in their protocol none of the patients who completed the protocol with consolidative PC experienced MIBC recurrence suggesting that consolidative PC may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after CRT
Our proposed Tetra-modal treatment protocol for MIBC is supposed to eliminate the surgical difficulties of performing PC in a radiated field and hence decrease the post operative complications of PC
About 25 of new diagnoses are muscle-invasive bladder cancer MIBC which carry a worse prognosis compared to non-muscle invasive disease
Neoadjuvant chemotherapy NAC followed by radical cystectomy RC with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of MIBC by multiple international guidelines
However this is associated with a significant impact on quality of life
The effect of our proposed Tetra-modal treatment protocol for muscle invasive Urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival cancer specific survival and overall survival
Koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor induction chemoradiation CRT and consolidative partial cystectomy PC with pelvic lymph node dissection allowing the confirmation of CRT response pathologically In the preliminary analysis of the initial cases enrolled in their protocol none of the patients who completed the protocol with consolidative PC experienced MIBC recurrence suggesting that consolidative PC may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after CRT
Our proposed Tetra-modal treatment protocol for MIBC is supposed to eliminate the surgical difficulties of performing PC in a radiated field and hence decrease the post operative complications of PC
Detailed Description:
None
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