NCT04740866

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High-Risk Cancer
• Urothelial Carcinoma Bladder

Interventions

Type	Name	Description
RADIATION	Adjuvant Radiotherapy	Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy (IMRT) technique. (\[50Gy in 25 fractions conventional fractionation including tumor bed \& pelvic lymph nodes\]

Timeline

• Start date: 2018-08-01
• Primary completion: 2021-12-31
• Completion: 2022-12-01
• First posted: 2021-02-05
• Last updated: 2021-02-09

Locations

1 site across 1 country: Egypt