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

Primary Purpose

Upper Tract Urothelial Carcinoma, Bladder Recurrence

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pharmorubicin or pirarubicin
Sponsored by
Xuesong Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Tract Urothelial Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Blank control

    single intravesical instillation

    multiple intravesical instillation

    Arm Description

    do not use prophylactic intravesical chemotherapy

    intravesical instillation within 24 hours postoperatively

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

    Outcomes

    Primary Outcome Measures

    intravesical recurrence-free survival

    Secondary Outcome Measures

    cancer-specific survival

    Full Information

    First Posted
    September 8, 2015
    Last Updated
    September 9, 2015
    Sponsor
    Xuesong Li
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02547350
    Brief Title
    Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xuesong Li

    4. Oversight

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Tract Urothelial Carcinoma, Bladder Recurrence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Blank control
    Arm Type
    No Intervention
    Arm Description
    do not use prophylactic intravesical chemotherapy
    Arm Title
    single intravesical instillation
    Arm Type
    Experimental
    Arm Description
    intravesical instillation within 24 hours postoperatively
    Arm Title
    multiple intravesical instillation
    Arm Type
    Experimental
    Arm Description
    intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months
    Intervention Type
    Drug
    Intervention Name(s)
    pharmorubicin or pirarubicin
    Intervention Description
    pharmorubicin 50mg pirarubicin 30mg
    Primary Outcome Measure Information:
    Title
    intravesical recurrence-free survival
    Time Frame
    two years after surgery
    Secondary Outcome Measure Information:
    Title
    cancer-specific survival
    Time Frame
    two years after surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who were clinically diagnosed with UTUC Treated with radical nephroureterectomy Exclusion Criteria: Distant metastasis Prior history of bladder or synchronous bladder cancer Administration of neoadjuvant chemotherapy Presence of severe complications.

    12. IPD Sharing Statement

    Learn more about this trial

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

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