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
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|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|
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-
- 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.
- 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.
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
|Urology and Nephrology Center|
|Mansourah, DK, Egypt, 35516|
|Study Director:||Yasser M. Osman, MD||Urology And Nephrology Center, Mansoura University, Mansoura|