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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02923557
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : November 17, 2016
Information provided by (Responsible Party):
Xuesong Li, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Bladder Recurrence Upper Tract Urothelial Carcinoma Nephroureterectomy Drug: Pirarubicin Phase 2

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2016
Estimated Primary Completion Date : November 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Blank control
do not use prophylactic intravesical chemotherapy.
Experimental: Single intravesical instillation
intravesical instillation within 24 hours postoperatively
Drug: Pirarubicin
single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of nephroureterectomy.

Primary Outcome Measures :
  1. intravesical recurrence-free survival [ Time Frame: three years after surgery ]

Secondary Outcome Measures :
  1. cancer-specific survival [ Time Frame: three years after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02923557

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Contact: Xuesong LI, M.D. 8601083572481

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China, Beijing
Peking University Frist Hospital Recruiting
Beijing, Beijing, China, 10034
Contact: Gengyan XIONG         
Contact: Runqi GUO         
Sponsors and Collaborators
Peking University First Hospital

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Responsible Party: Xuesong Li, Associated Professor, Peking University First Hospital Identifier: NCT02923557    
Other Study ID Numbers: IUPU-16-UTUC-2
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Antineoplastic Agents