Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas

NCT ID: NCT02547350

Last Updated: 2015-09-11

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).

Detailed Description

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Conditions

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Upper Tract Urothelial Carcinoma Bladder Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Blank control

do not use prophylactic intravesical chemotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

single intravesical instillation

intravesical instillation within 24 hours postoperatively

Group Type EXPERIMENTAL

pharmorubicin or pirarubicin

Intervention Type DRUG

pharmorubicin 50mg pirarubicin 30mg

multiple intravesical instillation

intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months

Group Type EXPERIMENTAL

pharmorubicin or pirarubicin

Intervention Type DRUG

pharmorubicin 50mg pirarubicin 30mg

Interventions

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pharmorubicin or pirarubicin

pharmorubicin 50mg pirarubicin 30mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who were clinically diagnosed with UTUC
2. Treated with radical nephroureterectomy

Exclusion Criteria

1. Distant metastasis
2. Prior history of bladder or synchronous bladder cancer
3. Administration of neoadjuvant chemotherapy
4. Presence of severe complications.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuesong Li

OTHER

Sponsor Role lead

Responsible Party

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Xuesong Li

professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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PIC-UTUC

Identifier Type: -

Identifier Source: org_study_id

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