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

Last updated: February 8, 2021
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Cancer

Bladder Cancer

Treatment

N/A

Clinical Study ID

NCT04740866
Bladder-03
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Patient with muscle-invasive urothelial cancer, who received neoadjuvant chemotherapyfollowed by radical cystectomy and urinary diversion with negative safety margin andbelongs 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

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 hampercompliance with the study and/ or follow up schedule.

Study Design

Total Participants: 100
Study Start date:
August 01, 2018
Estimated Completion Date:
December 01, 2022

Study 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.

Connect with a study center

  • National Cancer Institute-Cairo University

    Cairo, 11465
    Egypt

    Active - Recruiting

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