Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma
NCT ID: NCT03030157
Last Updated: 2019-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
220 participants
INTERVENTIONAL
2017-01-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
pirarubicin(THP)
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.
pirarubicin(THP)
Interventions
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pirarubicin(THP)
Eligibility Criteria
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Inclusion Criteria
* have no distant metastasis
* have an ECOG 0 to 2
* expected to receive radical nephroureterectomy
Exclusion Criteria
* administration of neoadjuvant chemotherapy
* the presence of severe complications
* deny to receive cytoscopy
* patients with advanced stage (T4)
* patients with contralateral UTUCs
18 Years
ALL
No
Sponsors
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Shanghai Pudong Hospital
OTHER
Shanghai Pudong New Area Gongli Hospital
OTHER
RenJi Hospital
OTHER
Responsible Party
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Yiran Huang
Director of Urology department in Renji Hospital
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RenJiH-PDU Trial
Identifier Type: -
Identifier Source: org_study_id
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