Clinical trial NCT05503563: A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder
Official title: A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: Tetramodal bladder preservation
urothelial carcinoma
partial cystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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,

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.


Eligibility 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.

Primary outcomes:
measure: local recurrence rate
timeFrame: the patient will be evaluted after partial cystectomy every 3 months for 2 years
measure: over active bladder symptom score
timeFrame: this questionnaire will be carried every 6 month for at least 2 years after the partial cystectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university
state: Assuit
Study officials:
affiliation: cheif of urological oncology department
name: Diaa A Sayed, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
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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.