Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas

Phase 2

• Conditions: Upper Tract Urothelial Carcinoma; Bladder Recurrence
• Interventions: Drug: pharmorubicin or pirarubicin

• Registration Number: NCT02547350
• Lead Sponsor: Xuesong Li

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-09
• Last Update Submitted: 2015-09-09
• Study First Posted: 2015-09-11
• Last Update Posted: 2015-09-11
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients who were clinically diagnosed with UTUC
2. Treated with radical nephroureterectomy

Exclusion Criteria

1. Distant metastasis
2. Prior history of bladder or synchronous bladder cancer
3. Administration of neoadjuvant chemotherapy
4. Presence of severe complications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multiple intravesical instillation	pharmorubicin or pirarubicin	intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months
single intravesical instillation	pharmorubicin or pirarubicin	intravesical instillation within 24 hours postoperatively

Primary Outcome Measures

Name	Time	Method
intravesical recurrence-free survival	two years after surgery

Secondary Outcome Measures

Name	Time	Method
cancer-specific survival	two years after surgery