High-Risk Cancer, Urothelial Carcinoma Bladder
Conditions
Keywords
Adjuvant Radiotherapy, Neoadjuvant chemotherapy, Radical Cystectomy, high risk Urothelial Carcinoma Bladder, Local Control, Disease Free Survival (DFS)
Brief summary
This is a prospective randomized clinical trial in high risk urothelial bladder cancer to compare adjuvant radiotherapy versus observation after radical cyctectomy. This is to clarify the benefit of adjuvant radiotherapy while limiting gastrointestinal toxicities for patients with pathological high-risk bladder cancer through assessing locoregional control (LRC).
Detailed description
This is prospective randomized trial in high risk urothelial bladder cancer that includes 2 arms. The randomization will be done by permuted block method to 2 equal comparable groups. The total number of subjects will be 50 in each arm (Total=100 subjects). This study include patients who may receive neoadjuvant chemotherapy \[Gemcitabine+Cisplatin\]) or not. Arm (1) in this study (N=50) will received irradiation of both the bladder tumor bed and pelvic lymph nodes using IMRT technique. For Arm (2) (N=50) will undergo observation following radical cystectomy.
Interventions
RADIATIONAdjuvant Radiotherapy
Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy (IMRT) technique. (\[50Gy in 25 fractions conventional fractionation including tumor bed & pelvic lymph nodes\]
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient with muscle-invasive urothelial cancer, who received neoadjuvant chemotherapy followed by radical cystectomy and urinary diversion with negative safety margin and belongs to one or more of the categories: * ≥ 18 years old. * PT3 or PT4a tumors. * Grade 3 urothelial cancer. * Positive infiltration of the dissected pelvic lymph nodes.
Exclusion criteria
* Residual tumors upon cystectomy. * Previous pelvic irradiation. * Non-urothelial bladder tumors. * WHO performance status above 2. * Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Control | Two year | 2-year local-regional control rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | Two year | 2-year disease free survival rate |
Countries
Egypt
Contacts
Primary ContactMohamed Zaghloul, MD
Outcome results
None listed