Trimodality Bladder Preservation

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

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...

Study Overview

• Status: Completed
• Conditions: Bladder Cancer Treatment
• Intervention / Treatment: Procedure: Transurethral resection of bladder tumor: We are aimed at Complete TURBT. Which was defined as no residual tumor, whereas incomplete TURBT

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].

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Azhar Assiut faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: clinical case's of muscle invasive bladder cancer .T2 or more bladder cancer according to the American Joint Committee on Cancer (AJCC) staging system.

• Age >18 years old. .Adequate bone marrow function. .Adequate renal functions. .Adequate hepatic functions.

Exclusion criteria:

.Distant metastases, pelvic lymph node metastasis. .Evidence of tumor-related hydronephrosis. .Severe irritative bladder symptoms.

• Persistent infection. .Associated serious medical or psychiatric illness. .Prior or concurrent malignancy of any other site unless the patient was disease free for 5 years.

.Previous systemic chemotherapy or pelvic irradiation. .Pregnant or lactating female patients. .Each patient will give written informed consent before entering the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T2 bladder cancer; T2 patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical ,radiological response , diagnostic cystoscopy and turbt biopsy either before and after neo adjuvant chemotherapy. Assessed response either complete, partial or progressive . according to tumor size,site ,stage, biopsy ( complete or incomplete	4 years

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• https://pubmed.ncbi.nlm.nih.gov/23485231/

Helpful Links

• Pub med

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Bladder cancer treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No