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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503563
• Other study ID #: AssuitUUro
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: September 15, 2024

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: Abdelrahman Atef Ali, master degree
• Phone: 00201000318832
• Email: Abdelrahman_atefuro93[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

Intervention

Procedure:
• terta modal bladder preservation
neoadjuvant chemotherapy, partial cystectomy, radiotherapy

Locations

Country	Name	City	State
Egypt	Assuit university	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25. Review. — View Citation

Felix AS, Soliman AS, Khaled H, Zaghloul MS, Banerjee M, El-Baradie M, El-Kalawy M, Abd-Elsayed AA, Ismail K, Hablas A, Seifeldin IA, Ramadan M, Wilson ML. The changing patterns of bladder cancer in Egypt over the past 26 years. Cancer Causes Control. 2008 May;19(4):421-9. doi: 10.1007/s10552-007-9104-7. Epub 2008 Jan 10. — View Citation

Kulkarni GS, Black PC, Sridhar SS, Kapoor A, Zlotta AR, Shayegan B, Rendon RA, Chung P, van der Kwast T, Alimohamed N, Fradet Y, Kassouf W. Canadian Urological Association guideline: Muscle-invasive bladder cancer. Can Urol Assoc J. 2019 Jan 31:230-238. doi: 10.5489/cuaj.5902. [Epub ahead of print] — View Citation

Noone AM, Cronin KA, Altekruse SF, Howlader N, Lewis DR, Petkov VI, Penberthy L. Cancer Incidence and Survival Trends by Subtype Using Data from the Surveillance Epidemiology and End Results Program, 1992-2013. Cancer Epidemiol Biomarkers Prev. 2017 Apr;26(4):632-641. doi: 10.1158/1055-9965.EPI-16-0520. Epub 2016 Dec 12. — View Citation

Singh AK, Shukla PK, Khan SW, Rathee VS, Dwivedi US, Trivedi S. Using the Modified Clavien Grading System to Classify Complications of Percutaneous Nephrolithotomy. Curr Urol. 2018 Feb;11(2):79-84. doi: 10.1159/000447198. Epub 2017 Dec 30. — View Citation

Outcome

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