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

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ClinicalTrials.gov Identifier: NCT04740866
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed s. Zaghloul, Cairo University

Study Description
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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).

Condition or disease Intervention/treatment Phase
High-Risk Cancer Urothelial Carcinoma Bladder Radiation: Adjuvant Radiotherapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Local Control [ Time Frame: Two year ]
    2-year local-regional control rate


Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: Two year ]
    2-year disease free survival rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740866


Contacts
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Contact: Mohamed Zaghloul, MD (20)-01001720664 mszagh@yahoo.com

Locations
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Egypt
National Cancer Institute-Cairo University Recruiting
Cairo, Egypt, 11465
Contact: Mohamed Zaghloul, MD    (20)01001720664    mszagh@yahoo.com   
Principal Investigator: Mohamed Zaghloul, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohamed Zaghloul, MD mszagh@yahoo.com
More Information
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Publications of Results:

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Responsible Party: Mohamed s. Zaghloul, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT04740866    
Other Study ID Numbers: Bladder-03
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed s. Zaghloul, Cairo University:
Adjuvant Radiotherapy
Neoadjuvant chemotherapy
Radical Cystectomy
 high risk Urothelial Carcinoma Bladder
Local Control
Disease Free Survival (DFS)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases