Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Diagnostic Ureteroscopy for Primary Upper Tract Urothelial Carcinoma Patients
NCT ID: NCT02740426
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2016-08-31
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Blank control
do not use prophylactic intravesical chemotherapy.
No interventions assigned to this group
Single intravesical instillation
intravesical instillation within 24 hours postoperatively
Pirarubicin
single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of ureteroscopy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pirarubicin
single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of ureteroscopy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suspected UTUC patients without synchronous bladder tumor.
* Suspected UTUC patients without contralateral UTUCs.
Exclusion Criteria
* Patients with synchronous bladder tumor.
* Patients with contralateral UTUCs.
* Patients with advanced stage (T4).
* Patients with other malignant tumors.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University First Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xuesong Li
Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Xuesong Li, M.D.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gengyan XIONG, M.D.
Role: primary
Runqi GUO, M.D.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IUPU-16-UTUC
Identifier Type: -
Identifier Source: org_study_id