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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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High-Risk Cancer, Urothelial Carcinoma Bladder

Intervention / Treatment
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* Radiation: Adjuvant Radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adjuvant Radiotherapy<br>Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy [IMRT] technique. | Radiation: Adjuvant Radiotherapy<br>* 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]<br>|
| No Intervention: Observation after radical Cystectomy<br>observation following radical cystectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control | 2-year local-regional control rate | Two year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival | 2-year disease free survival rate | Two year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local Control, Adjuvant Radiotherapy, Neoadjuvant chemotherapy, Radical Cystectomy, high risk Urothelial Carcinoma Bladder, Disease Free Survival (DFS)