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

Cairo University (CU)

Status: Unknown

Conditions: Urothelial Carcinoma Bladder; High-Risk Cancer

Treatments: Radiation: Adjuvant Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04740866

Bladder-03

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Adjuvant Radiotherapy

Active Comparator group

Description:

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

Treatment:

Radiation: Adjuvant Radiotherapy

Observation after radical Cystectomy

No Intervention group

Description:

observation following radical cystectomy