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

February 8, 2021 updated by: Mohamed s. Zaghloul, Cairo University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11465
        • Recruiting
        • National Cancer Institute-Cairo University
        • Contact:
        • Principal Investigator:
          • Mohamed Zaghloul, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed Zaghloul, MD, mszagh@yahoo.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bladder-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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