Back to resultsProphylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
Primary Purpose
Upper Tract Urothelial Carcinoma, Bladder Recurrence
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pharmorubicin or pirarubicin
Sponsored by
About this trial
This is an interventional prevention trial for Upper Tract Urothelial Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients who were clinically diagnosed with UTUC
- Treated with radical nephroureterectomy
Exclusion Criteria:
- Distant metastasis
- Prior history of bladder or synchronous bladder cancer
- Administration of neoadjuvant chemotherapy
- Presence of severe complications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Blank control
single intravesical instillation
multiple intravesical instillation
Arm Description
do not use prophylactic intravesical chemotherapy
intravesical instillation within 24 hours postoperatively
intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months
Outcomes
Primary Outcome Measures
intravesical recurrence-free survival
Secondary Outcome Measures
cancer-specific survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547350
Brief Title
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuesong Li
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Tract Urothelial Carcinoma, Bladder Recurrence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blank control
Arm Type
No Intervention
Arm Description
do not use prophylactic intravesical chemotherapy
Arm Title
single intravesical instillation
Arm Type
Experimental
Arm Description
intravesical instillation within 24 hours postoperatively
Arm Title
multiple intravesical instillation
Arm Type
Experimental
Arm Description
intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months
Intervention Type
Drug
Intervention Name(s)
pharmorubicin or pirarubicin
Intervention Description
pharmorubicin 50mg pirarubicin 30mg
Primary Outcome Measure Information:
Title
intravesical recurrence-free survival
Time Frame
two years after surgery
Secondary Outcome Measure Information:
Title
cancer-specific survival
Time Frame
two years after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who were clinically diagnosed with UTUC
Treated with radical nephroureterectomy
Exclusion Criteria:
Distant metastasis
Prior history of bladder or synchronous bladder cancer
Administration of neoadjuvant chemotherapy
Presence of severe complications.
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
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