Clinical trial NCT02740426: Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Diagnostic Ureteroscopy for Primary Upper Tract Urothelial Carcinoma Patients
Official title: Peking University First Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Upper Tract Urothelial Carcinoma
Bladder Recurrence
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed description: INTRODUCTION

Upper tract urothelial carcinomas (UTUC) are relatively uncommon compared to bladder cancer and account for only 5-10% of urothelial carcinomas \[Munoz et al., 2000; Siegel et al., 2012; Rouprêt et al. 2015\], with an estimated annual incidence in Western countries of \~2 cases per 100,000 inhabitants. In 17% of cases, concurrent bladder cancer is present \[Cosentino et al., 2013\].

Urinary cytology, cystoscopy and computed tomograpy urography should be performed as the standard diagnostic work-up with the grade A of recommendation \[Rouprêt et al., 2015\]. Diagnostic ureteroscopy and biopsy should be performed, certainly in cases where additional information will impact treatment decisions. Such ureteroscopic biopsies can determine tumour grade in 90% of cases with a low false-negative rate \[Rojas et al., 2012\]. Ureteroscopy can prove invaluable in cases of suspected UTUC, especially when the diagnosis is equivocal, or if nephron sparing surgery is considered. However, it can pose potential hindrances, including difficulty in obtaining adequate tissue, inconsistent pathologic interpretation and prediction, and a high rate of upgrading and upstaging at the time of nephroureterectomy \[Potretzke et al., 2015\].

Recurrence in the bladder after management of UTUC occurs in 22-47% of UTUC patients \[Xylinas et al., 2012; Zigeuner et al., 2006; Novara et al., 2008\], compared with 2-6% in the contralateral upper tract \[Li et al., 2010; Novara et al., 2009\]. At our institution, we reported that 30.8% of UTUC patients developed intravesical recurrence, which was in line with the global trend \[Fang et al., 2013\]. Although the risk factors for development of bladder tumor post surgical management of UTUC were previously studied, considerable variations were observed in the literature. In previously published studies, we pointed out that lower tumor grade, tumor multifocality, concomitant carcinoma in situ (CIS), tumors located in the lower ureter, ureteroscopy history and unmethylated promoter of GDF15 and RASSF1A promoters were considered as predictors to develop bladder recurrence after surgery by univariate and multivariate analysis \[Fang et al., 2013, Xiong et al., 2015\]. As an effective tool to evaluate UTUCs visually or by biopsy, ureteroscopy was selectively used in early UTUC patients without atypical radiography. It was our hypothesis that retrograde flow, increased urine flow rate and intraluminal pressure might lead to the shedding of tumor cells (intraluminal tumor seeding is thought to contribute to intravesical recurrence after nephroureterectomy), which implant in the bladder to develop recurrences \[Xiong et al., 2015\].

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 diagnostic ureteroscopy for UTUCs.

Eligibility criteria: 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.

Primary outcomes:
measure: intravesical recurrence-free survival
timeFrame: three years after surgery
Secondary outcomes:
measure: cancer-specific survival
timeFrame: three years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: