Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT03030157|
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intravesical Instillation||Drug: pirarubicin(THP)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Long-term Intravesical Instillation of pirarubicin(THP)
A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The ﬁrst instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.
Active Comparator: Single Intravesical Instillation of pirarubicin
A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.
- The incidence of bladder cancer in the first 12 month following nephroureterectomy [ Time Frame: 12 month ]Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 day, 1 month and 12 month ]
- questionnaire for quality of life [ Time Frame: baseline, 1 month and 12 month ]e.g QLQ C-30
- progression-free survival [ Time Frame: 12 month ]progression-free survival
- cancer-specific survival [ Time Frame: 12 month ]cancer-specific survival
- overall survival [ Time Frame: 12 month ]overall survival
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): NCT03030157
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