Radical Cystectomy Versus Tri-Modal Therapy for Treatment of cT2N0M0 Urinary Bladder Transitional Cell Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Disease free survival
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults of any gender, aged 18 years or older.
- •Histologically confirmed urothelial (transitional cell) carcinoma (TCC) of the urinary bladder, clinical stage T2N0M0, diagnosed through:
- •Imaging (CT or MRI).
- •Cystoscopy.
- •Biopsy and histopathological examination of the tumor.
Exclusion Criteria
- •Evidence of significant nodal involvement on imaging.
- •Presence of carcinoma in situ (CIS).
- •Hydronephrosis attributed to the bladder tumor.
- •Non-TCC histology of bladder cancer.
- •TCC with atypical histological variants including:
- •Micropapillary,
- •Plasmacytoid,
- •Anaplastic, or
- •Sarcomatoid variants.
- •High-grade non-muscle invasive bladder cancer (NMIBC).
- •Patients unfit for surgery.
- •Patients unfit for chemotherapy or radiotherapy.
- •Refusal to undergo randomization.
- •Prior chemotherapy or radiotherapy for bladder cancer.
Arms & Interventions
Radical Cystectomy group
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.
Intervention: Radical cystectomy with pelvic lymphadenectomy (Other)
Trimodal therapy 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
Intervention: Trimodal therapy (Radiation)
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 3 years
Cancer specific survival
Time Frame: 3 years
Overall survival
Time Frame: 3 years
Secondary Outcomes
- Complications of intervention(3 years)
Investigators
Ahmed Himdan Abdelhameed
Assistant Lecturer of Urology
Ain Shams University