Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

Phase 2

• Conditions: Intravesical Instillation
• Interventions: Drug: pirarubicin(THP)

• Registration Number: NCT03030157
• Lead Sponsor: RenJi Hospital

Brief Summary

Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• clinically diagnosed with upper tract urothelial carcinoma
• have no distant metastasis
• have an ECOG 0 to 2
• expected to receive radical nephroureterectomy

Exclusion Criteria

• a prior history of bladder or synchronous bladder cancer
• administration of neoadjuvant chemotherapy
• the presence of severe complications
• deny to receive cytoscopy
• patients with advanced stage (T4)
• patients with contralateral UTUCs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long-term Intravesical Instillation of pirarubicin(THP)	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.
Single Intravesical Instillation of pirarubicin	pirarubicin(THP)	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.

Primary Outcome Measures

Name	Time	Method
The incidence of bladder cancer in the first 12 month following nephroureterectomy	12 month	Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.

Secondary Outcome Measures

Name	Time	Method
cancer-specific survival	12 month	cancer-specific survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	2 day, 1 month and 12 month
questionnaire for quality of life	baseline, 1 month and 12 month	e.g QLQ C-30
progression-free survival	12 month	progression-free survival
overall survival	12 month	overall survival

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China