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

Not Applicable

• Conditions: High-Risk Cancer; Urothelial Carcinoma Bladder
• Interventions: Radiation: Adjuvant Radiotherapy

• Registration Number: NCT04740866
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant Radiotherapy	Adjuvant Radiotherapy	Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy \[IMRT\] technique.

Primary Outcome Measures

Name	Time	Method
Local Control	Two year	2-year local-regional control rate

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	Two year	2-year disease free survival rate

Trial Locations

Locations (1)

National Cancer Institute-Cairo University; 🇪🇬 Cairo, Egypt