NCT07402317

Trimodality Bladder Preservation

Outcome of a New Trimodality Bladder Perservation Protocol for Patients With Muscle Invasive Bladder Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is To evaluate the outcomes of patients with muscle invasive bladder cancer managed by trimodal therapy", Neoadjuvant chemotherapy( NAC) followed by Transurethral resection of the bladder tumor then Radiotherapy, for bladder preservation and capability to reach the goal of better quality of life, compared to radical cystectomy with assessment of factors that may predict treatment response, risk of recurrences and (disease- free and over all)survival of such patients...

Detailed description

Bladder Cancer (BC) is a worldwide health problem. It is the 7th most commonly diagnosed cancer in male population worldwide, whilst it drops to 11th for both sexes. Approximately 25% of newly diagnosed patients have muscle-invasive disease. Despite potentially curative radical surgery, approximately 50% of muscle invasive cases develop relapse within 2 years, and most of them die. Organ preservation has been the main goal of cancer care in the last two decades, yet it is not generally adopted for the cure of non-metastatic muscle invasive bladder cancer\[1\]. The standard of care for muscle invasive urothelial-cell carcinoma (UCC) of the bladder is radical cystectomy (RC). Radical surgery results in long-term survival rates of 40%-60% \[2-4\]. Sophisticated techniques for urinary diversion have been developed to improve patients' quality of life; however, this cannot substitute for the patient's original bladder \[5\]. Attempts to obtain bladder preservation are only justified when they have a high likelihood of achieving local cure with no compromise in survival rates. Transurethral resection of the bladder tumor (TURBT) alone, chemotherapy alone or radiation therapy alone provide inferior outcomes to radical cystectomy with only 20% to 40% local control rates in muscle invasive urothelial-cell carcinoma (UCC). Several groups have reported the value of combining all three modalities, with salvage cystectomy being reserved for patients with incomplete response or local relapse \[6,7\]. Bladder preservation approaches became increasingly favored, and became successful , essentially after the emergence of concurrent chemo-radiation protocols with cisplatin. The National Bladder Cancer Group first demonstrated the safety and efficacy of cisplatin, as a radiation sensitizer, in patients with MIBC who were unsuitable for cystectomy\[8\].

Conditions

• Bladder Cancer Treatment

Interventions

Type	Name	Description
PROCEDURE	Transurethral resection of bladder tumor: We are aimed at Complete TURBT. Which was defined as no residual tumor, whereas incomplete TURBT	Neo adjuvant chemotherapy followed by turbt followed by radiotherapy

Timeline

• Start date: 2018-12-11
• Primary completion: 2022-09-01
• Completion: 2023-01-25
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Egypt