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Trial Title:
A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder
NCT ID:
NCT05503563
Condition:
Bladder Cancer
Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Conditions: Keywords:
Tetramodal bladder preservation
urothelial carcinoma
partial cystectomy
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
terta modal bladder preservation
Description:
neoadjuvant chemotherapy, partial cystectomy, radiotherapy
Arm group label:
tetra modal bladder preservation
Summary:
In Egypt, bladder cancer has been the most common cancer during the past 50 years. In
2002, Egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing
approximately 30,000 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.
Criteria for eligibility:
Study pop:
patient presented with bladder cancer whom are under treatment with multiple modalities
such as endoscopic resection , chemotherapy , radiotherapy & partial cystectomy,
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Tumor size ≤ 50 % of bladder surface or multiple tumors in an area of the bladder
that is ≤ 50 % of total bladder surface.
2. Tumor at least 2 cm away from bladder neck or trigone.
3. Clinically, no residual disease or minimal amounts of non-invasive disease in the
original MIBC site after NAC at restaging TURBT (if done).
4. Pathologically confirmed urothelial carcinoma.
Exclusion Criteria:
1. Prescence of CIS.
2. Presence of distant metastasis.
3. Patients unfit for cisplatin-based chemotherapy.
Gender:
All
Minimum age:
20 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Assuit university
Address:
City:
Assiut
Zip:
71511
Country:
Egypt
Status:
Recruiting
Start date:
July 15, 2022
Completion date:
September 15, 2024
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05503563
