NCT02547350

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).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

5.3 years

First QC Date

September 8, 2015

Last Update Submit

September 9, 2015

Conditions

Upper Tract Urothelial CarcinomaBladder Recurrence

Outcome Measures

Primary Outcomes (1)

  • intravesical recurrence-free survival

    two years after surgery

Secondary Outcomes (1)

  • cancer-specific survival

    two years after surgery

Study Arms (3)

Blank control

NO INTERVENTION

do not use prophylactic intravesical chemotherapy

single intravesical instillation

EXPERIMENTAL

intravesical instillation within 24 hours postoperatively

Drug: pharmorubicin or pirarubicin

multiple intravesical instillation

EXPERIMENTAL

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

Drug: pharmorubicin or pirarubicin

Interventions

pharmorubicin or pirarubicinDRUG

pharmorubicin 50mg pirarubicin 30mg

multiple intravesical instillationsingle intravesical instillation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were clinically diagnosed with UTUC
  • Treated with radical nephroureterectomy

You may not qualify if:

  • Distant metastasis
  • Prior history of bladder or synchronous bladder cancer
  • Administration of neoadjuvant chemotherapy
  • Presence of severe complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Epirubicinpirarubicin

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 11, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2020

Last Updated

September 11, 2015

Record last verified: 2015-09