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A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder

A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05503563
Enrollment
50
Registered
2022-08-16
Start date
2022-07-15
Completion date
2024-09-15
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Tetramodal bladder preservation, urothelial carcinoma, partial cystectomy

Brief 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.

Interventions

PROCEDUREterta modal bladder preservation

neoadjuvant chemotherapy, partial cystectomy, radiotherapy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
local recurrence ratethe patient will be evaluted after partial cystectomy every 3 months for 2 yearsthe patient will be evaluated using MRI and cystoscopy
over active bladder symptom scorethis questionnaire will be carried every 6 month for at least 2 years after the partial cystectomythe patient will be asked about his symptoms using a questionnaire that is concerned about urgency , frequency , urge incontinence .

Countries

Egypt

Contacts

Primary ContactAbdelrahman Atef Ali, master degree
Abdelrahman_atefuro93@yahoo.com00201000318832
Backup ContactDiaa A Sayed, PhD
diaa_hameed@hotmail.com01203888849

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026