Upper Tract Urothelial Carcinoma Clinical Trial
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02547350 -
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
|
Phase 2 | |
| Recruiting |
NCT04948528 -
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
|
||
| Recruiting |
NCT05917158 -
A Study of RC48-ADC Combined With JS001 For Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
|
Phase 2 | |
| Recruiting |
NCT02969083 -
Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma
|
Phase 2 | |
| Recruiting |
NCT03544437 -
Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma
|
||
| Recruiting |
NCT03230201 -
Lymph Node Dissection in High-risk UTUC(Upper Tract Urothelial Carcinoma)
|
N/A | |
| Recruiting |
NCT02740426 -
Prophylactic Intravesical Chemotherapy to Prevent Bladder Recurrence After Diagnostic Ureteroscopy for Primary Upper Tract Urothelial Carcinoma Patients
|
Phase 2 | |
| Active, not recruiting |
NCT03617003 -
Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)
|
Phase 1 |