An interventional study of Radical cystectomy with pelvic lymphadenectomy and Trimodal therapy in Transitional Cell Bladder Cancer, Cystectomy and Radiation, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
the aim of this study is to compare the oncological outcome of trimodal therapy with bladder preservation using maximal resection with chemoradiation versus the standard radical cystectomy for muscle invasive transitional cell carcinoma of urinary bladder.
Bladder cancer is the 9th most common cancer in the world, accounting for approximately 5-8% of all male cancers which makes it the 4th most common cancer in men and accounts for approximately 2% of female cancers making it the 8th most common cancer among women .
Bladder cancer is the 2nd most common urogenital cancer; thus, it is considered a very frequent disease to deal with in urological practice .
The urinary bladder is lined internally with transitional epithelial cells (urothelium), followed by lamina propria which is formed of connective tissue supporting the overlying urothelium, then muscularis propria (detrusor muscle) followed by an outer layer called serosa .
Bladder cancer is usually presented by gross or microscopic hematuria (85-90%), it may be associated with irritative symptoms, especially in the presence of carcinoma in situ.
In advanced disease, the patient may complain of bone pain, loin pain, pain radiating to the buttocks and thighs, or even renal impairment due to obstruction of both lower ureters.
Diagnosis and staging of bladder cancer are multimodal approaches done through a combination of clinical, radiological, and histopathological means.
Magnetic resonant imaging MRI lacks ionizing radiation, so it is considered a safe way to investigate a patient with cancer bladder before, during, or following up the treatment to determine its response .
Diagnostic cystoscopy is the only definitive diagnostic tool through histopathological examination of the resected tissues. Proper sampling should include the underlying muscularis propria. Transurethral resection of bladder tumor (TURBT) can miss proper muscle layer sampling in 25% of invasive cancer leading to under-staging. TURBT depends on the surgeon's experience, so the tumor-free rate varies widely .
Differentiation between non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) is a cornerstone in the treatment plans. Treatment methods aim at preserving the quality of life and reduce stage progression. The usual conservative approach in MIBC is a trimodal treatment (TMT). It consists of a transurethral resection of the bladder tumor (TURBT) as complete as possible, followed by concomitant radiotherapy (RT) and chemotherapy (CT). Response to radiotherapy and chemotherapy is then assessed by cystoscopy and biopsies. Planned surgery is proposed to non-responders and additional chemotherapy and RT with careful regular endoscopic examination is performed in responders .
Except for the incomplete selective bladder preservation against radical excision (SPARE) trial, there is no large and meaningful randomized trial comparing radical cystectomy and TMT .
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed urothelial (transitional cell) carcinoma (TCC) of the urinary bladder, clinical stage T2N0M0, diagnosed through:
Exclusion Criteria:
TCC with atypical histological variants including:
Gtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina). Standard pelvic lymph node dissection was performed to all patients in this group.
Other: Radical cystectomy with pelvic lymphadenectomy
Group B : trimodal therapy group the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges. This was followed by radio-sensitizing chemotherapy and radiotherapy.. Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2). Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY
Radiation: Trimodal therapy
Gtoup A : Radical cystectomy group Radical cystectomy included surgical removal of the bladder, adjacent organs, and regional lymph nodes. In males, it included removal of urinary bladder, prostate, and seminal vesicles whereas in females, it included removal of urinary bladder and reproductive organs (ovaries, fallopian tubes, uterus, and anterior vagina). Standard pelvic lymph node dissection was performed to all patients in this group.
Group B : trimodal therapy group the patients underwent maximal TURBT, where as much tumor as possible was completely resected using bipolar resectoscope. The goal was to remove all visible tumor including the underlying muscle layer and tumor edges. This was followed by radio-sensitizing chemotherapy and radiotherapy.. Chemotherapy consisted of weekly administration of iv infusion of cisplatin (40mg/m2). Radiotherapy delivered as EBRT aimed at delivering approximately 44- 46 Gy to the urinary bladder and pelvic lymphnodes.followed by additional boost to the bladder 54 GY and a final boost to the tumor 64-65 GY
Overall survival
Time frame: 3 years
Disease free survival
Time frame: 3 years
Cancer specific survival
Time frame: 3 years
Complications of intervention
Time frame: 3 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Study protocol, Sap, Csr, Analytic code
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ain Shams University