Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pirarubicin

do not use prophylactic intravesical chemotherapy.

intravesical instillation within 24 hours postoperatively

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

Xuesong LI, M.D.

Gengyan XIONG

Runqi GUO

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.

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.

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

Peking University First Hospital

Associated Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Transitional Cell Cancer of the Renal Pelvis and Ureter

Anti-Infective Agents

Epirubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

do not use prophylactic intravesical chemotherapy

intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months

pharmorubicin or pirarubicin

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).

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

Xuesong Li

professor

single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of ureteroscopy.

Xuesong Li, M.D.

Gengyan XIONG, M.D.

Runqi GUO, M.D.

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma Patients	NCT02923557	Bladder Recurre... Upper Tract Uro... Nephroureterect...	Pirarubicin	18 Years -	Peking University First Hospital
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas	NCT02547350	Upper Tract Uro... Bladder Recurre...	pharmorubicin o...	-	Peking University First Hospital
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas	NCT02547350	Upper Tract Uro... Bladder Recurre...	pharmorubicin o...	-	Peking University First Hospital
Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Diagnostic Ureteroscopy for Primary Upper Tract Urothelial Carcinoma Patients	NCT02740426	Upper Tract Uro... Bladder Recurre...	Pirarubicin	18 Years -	Peking University First Hospital

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