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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02438865 |
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Date of registration:
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06/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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January 1, 2015 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02438865 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Yasser M. Osman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Urology And Nephrology Center, Mansoura University, Mansoura |
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Key inclusion & exclusion criteria
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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)
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neoplasm, Bladder
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Neoplasm, Ureter
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Intervention(s)
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Drug: Immediate instillation of intravesical chemotherapy-Epirubicin-
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Drug: Maintainance therapy of intravesical chemotherapy-Epirubicin-
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Primary Outcome(s)
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bladder recurrence
[Time Frame: 1 year after surgery]
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Secondary Outcome(s)
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adverse events
[Time Frame: 1 year after surgery]
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Secondary ID(s)
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MElsh112015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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