Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma Patients

Upper Tract Urothelial Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02923557
• Other study ID #: IUPU-16-UTUC-2
• Status: Recruiting
• Phase: Phase 2
• First received: October 1, 2016
• Last updated: November 15, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Peking University First Hospital
• Contact: Xuesong LI, M.D.
• Phone: 8601083572481
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

This clinical trial is designed to evaluate the efficacy of single immediate intravesical chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy for primary upper tract urothelial carcinoma (UTUC) patients.

Description:

INTRODUCTION

Upper tract urothelial carcinomas (UTUC) are relatively uncommon compared to bladder cancer and account for only 5-10% of urothelial carcinomas, with an estimated annual incidence in Western countries of ~2 cases per 100,000 inhabitants. In 17% of cases, concurrent bladder cancer is present. Recurrence in the bladder after management of UTUC occurs in 22-47% of UTUC patients, compared with 2-6% in the contralateral upper tract. At our institution, we reported that 30.8% of UTUC patients developed intravesical recurrence, which was in line with the global trend.

Generally speaking, the field cancerization hypothesis and intraluminal seeding are currently the two main concepts to explain multifocality of urothelial cancer and the recurrent bladder tumor. Independent multiclonal tumor development after carcinogenic exposure of the entire urothelial and intraluminal implantation followed by clonally induced single progenitor cell evolution are the mechanisms suggested. While the two mechanisms could co-exist, the intraluminal seeding hypothesis is becoming more prevalent with the emergence of more evidence from molecular studies. Thus postoperative intravesical chemotherapy could potentially remove the implantation cell and prevent recurrence. While intravesical instillation is widely used to prevent recurrence after transurethral resection for primary bladder tumors, there is still no consensus on the prophylactic capability of intravesical chemotherapy in preventing bladder recurrence after nephroureterctomy for UTUC. According to a previous prospective, multicentre, randomised clinical trial, a single postoperative dose of intravesical mitomycin C appears to reduce the risk of a bladder tumour within the first year following nephroureterectomy for UTUCs.

AIM OF THE WORK This clinical trial is designed to evaluate the efficacy of single immediate intravesical chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy for UTUCs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspected UTUC patients without history of bladder tumor.

• Suspected UTUC patients without synchronous bladder tumor.

• Suspected UTUC patients without contralateral UTUCs.

Exclusion Criteria:

• Patients with history of bladder tumor.

• Patients with synchronous bladder tumor.

• Patients with contralateral UTUCs.

• Patients with advanced stage (T4).

• Patients with other malignant tumors.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bladder Recurrence
• Carcinoma
• Carcinoma, Transitional Cell
• Nephroureterectomy
• Recurrence
• Upper Tract Urothelial Carcinoma

Intervention

Drug:
• Pirarubicin
single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of nephroureterectomy.

Locations

Country	Name	City	State
China	Peking University Frist Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intravesical recurrence-free survival		three years after surgery	No
Secondary	cancer-specific survival		three years after surgery	No