Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

NCT ID: NCT03030157

Last Updated: 2019-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

Brief Summary

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Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.

Detailed Description

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Conditions

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Intravesical Instillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Long-term Intravesical Instillation of pirarubicin(THP)

A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The first instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.

Group Type EXPERIMENTAL

pirarubicin(THP)

Intervention Type DRUG

Single Intravesical Instillation of pirarubicin

A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.

Group Type ACTIVE_COMPARATOR

pirarubicin(THP)

Intervention Type DRUG

Interventions

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pirarubicin(THP)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* clinically diagnosed with upper tract urothelial carcinoma
* have no distant metastasis
* have an ECOG 0 to 2
* expected to receive radical nephroureterectomy

Exclusion Criteria

* a prior history of bladder or synchronous bladder cancer
* administration of neoadjuvant chemotherapy
* the presence of severe complications
* deny to receive cytoscopy
* patients with advanced stage (T4)
* patients with contralateral UTUCs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pudong Hospital

OTHER

Sponsor Role collaborator

Shanghai Pudong New Area Gongli Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yiran Huang

Director of Urology department in Renji Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jiwei huang

Role: CONTACT

8613651682825

Facility Contacts

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jiwei huang, M.D

Role: primary

8613651682825

jin zhang

Role: backup

86-21-68383776

Other Identifiers

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RenJiH-PDU Trial

Identifier Type: -

Identifier Source: org_study_id

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