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

NCT05503563 | Unknown

• 1 other identifier: AssuitUUro
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Tetramodal bladder preservation; urothelial carcinoma; partial cystectomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

tetra modal bladder preservation

Procedure: terta modal bladder preservation

Interventions

terta modal bladder preservation PROCEDURE

neoadjuvant chemotherapy, partial cystectomy, radiotherapy

tetra modal bladder preservation

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient presented with bladder cancer whom are under treatment with multiple modalities such as endoscopic resection , chemotherapy , radiotherapy \& partial cystectomy,

You may qualify if:

• Tumor size ≤ 50 % of bladder surface or multiple tumors in an area of the bladder that is ≤ 50 % of total bladder surface.
• Tumor at least 2 cm away from bladder neck or trigone.
• Clinically, no residual disease or minimal amounts of non-invasive disease in the original MIBC site after NAC at restaging TURBT (if done).
• Pathologically confirmed urothelial carcinoma.

You may not qualify if:

• Prescence of CIS.
• Presence of distant metastasis.
• Patients unfit for cisplatin-based chemotherapy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university

Asyut, Assuit, 71511, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 18188671 BACKGROUND

• 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.

  PMID: 22877502 BACKGROUND

• 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 Aug;13(8):230-238. doi: 10.5489/cuaj.5902. No abstract available.

  PMID: 30763236 BACKGROUND

• 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.

  PMID: 27956436 BACKGROUND

• 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.

  PMID: 29593466 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Diaa A Sayed, PhD

  cheif of urological oncology department

  STUDY DIRECTOR

Central Study Contacts

Abdelrahman Atef Ali, master degree

CONTACT

00201000318832; Abdelrahman_atefuro93@yahoo.com

Diaa A Sayed, PhD

CONTACT

01203888849; diaa_hameed@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist at Assuit University Hospital

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 16, 2022
• Study Start: July 15, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

EG (1)