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

Recruiting

• Conditions: Bladder Cancer
• Interventions: Procedure: terta modal bladder preservation

• Registration Number: NCT05503563
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2022-07-29
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-13
• Last Update Submitted: 2022-08-13
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16
• Primary Completion: 2024-09-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tetra modal bladder preservation	terta modal bladder preservation	-

Primary Outcome Measures

Name	Time	Method
local recurrence rate	the patient will be evaluted after partial cystectomy every 3 months for 2 years	the patient will be evaluated using MRI and cystoscopy
over active bladder symptom score	this questionnaire will be carried every 6 month for at least 2 years after the partial cystectomy	the patient will be asked about his symptoms using a questionnaire that is concerned about urgency , frequency , urge incontinence .

Trial Locations

Locations (1)

Assuit university; 🇪🇬 Assiut, Assuit, Egypt