Status:
UNKNOWN
Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
Lead Sponsor:
Cairo University
Conditions:
High-Risk Cancer
Urothelial Carcinoma Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04740866
Start Date
August 1 2018
End Date
December 1 2022
Last Update
February 9 2021
Active Locations (1)
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1
National Cancer Institute-Cairo University
Cairo, Egypt, 11465