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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02923557
Enrollment
200
Registered
2016-10-04
Start date
2016-11-30
Completion date
Unknown
Last updated
2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Recurrence, Upper Tract Urothelial Carcinoma, Nephroureterectomy

Brief 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.

Detailed 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.

Interventions

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

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
intravesical recurrence-free survivalthree years after surgery

Secondary

MeasureTime frame
cancer-specific survivalthree years after surgery

Countries

China

Contacts

Primary ContactXuesong LI, M.D.
8601083572481

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026