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Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer

Urothelial Carcinoma Bladder Clinical Trial

Official title:
Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04740866
Study type Interventional
Source Cairo University
Contact Mohamed Zaghloul, MD
Phone (20)-01001720664
Email mszagh@yahoo.com
Status Recruiting
Phase N/A
Start date August 1, 2018
Completion date December 1, 2022
View Details
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