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Trial record 9 of 26 for:    upper tract urothelial

Prophylactic Intravesical Chemotherapy After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Randomized Controlled Trial Between Single Postoperative Dose Versus Maintenance Therapy.

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ClinicalTrials.gov Identifier: NCT02438865
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Magdy Elshabrawy, Mansoura University

Brief Summary:
This clinical trial is designed to compare the effect of single postoperative intravesical chemotherapy instillation versus maintenance therapy on reducing bladder cancer recurrence after surgery for UTUC.

Condition or disease Intervention/treatment Phase
Neoplasm, Ureter Neoplasm, Bladder Drug: Immediate instillation of intravesical chemotherapy-Epirubicin- Drug: Maintainance therapy of intravesical chemotherapy-Epirubicin- Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prophylactic Intravesical Chemotherapy After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Randomized Controlled Trial Between Single Postoperative Dose Versus Maintenance Therapy.
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 30, 2018


Arm Intervention/treatment
Active Comparator: Single instillation group
will receive single intravesical dose of epirubicin intravesical therapy (50 mg) within 48 hours of radical nephroureterectomy with open bladder cuff excision.
Drug: Immediate instillation of intravesical chemotherapy-Epirubicin-
Active Comparator: Maintainance therapy group
will receive a single intravesical dose of epirubicin and an additional 6 weekly doses of intravesical therapy (50 mg) after surgery then monthly maintenance therapy for 1 year.
Drug: Maintainance therapy of intravesical chemotherapy-Epirubicin-



Primary Outcome Measures :
  1. bladder recurrence [ Time Frame: 1 year after surgery ]
    The primary outcome of the study is the diagnosis of intravesical recurrence within the first year after surgery.


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 1 year after surgery ]
    The secondary outcome is to determine the adverse events postoperative morbidity, mortality and survival of patients with UTUC.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with UTUC without history of bladder tumor
  2. Patients with UTUC without synchronous bladder tumor

Exclusion Criteria:

  1. Patients with history of bladder tumor
  2. Patients with synchronous bladder tumor
  3. Patients with advanced stage (T4)

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): NCT02438865


Locations
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Egypt
Urology and Nephrology Center
Mansourah, DK, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Director: Yasser M. Osman, MD Urology And Nephrology Center, Mansoura University, Mansoura

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Responsible Party: Magdy Elshabrawy, Fellow in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt, Mansoura University
ClinicalTrials.gov Identifier: NCT02438865     History of Changes
Other Study ID Numbers: MElsh112015
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Keywords provided by Magdy Elshabrawy, Mansoura University:
Upper Tract Urothelial Carcinoma
Intravesical Chemotherapy
Epirubicin
Urothelial Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action