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

September 9, 2015 updated by: Xuesong Li
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Blank control
do not use prophylactic intravesical chemotherapy
Experimental: single intravesical instillation
intravesical instillation within 24 hours postoperatively
Drug: pharmorubicin or pirarubicin
pharmorubicin 50mg pirarubicin 30mg
Experimental: multiple intravesical instillation
intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months
Drug: pharmorubicin or pirarubicin
pharmorubicin 50mg pirarubicin 30mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intravesical recurrence-free survival
Time Frame: two years after surgery
two years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
cancer-specific survival
Time Frame: two years after surgery
two years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuesong Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC-UTUC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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