NCT02923557

Brief Summary

This clinical trial is designed to evaluate the efficacy of single immediate intravesical chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy for primary upper tract urothelial carcinoma (UTUC) patients.

Trial Health

55
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

5 years

First QC Date

October 1, 2016

Last Update Submit

November 15, 2016

Conditions

Bladder RecurrenceUpper Tract Urothelial CarcinomaNephroureterectomy

Outcome Measures

Primary Outcomes (1)

  • intravesical recurrence-free survival

    three years after surgery

Secondary Outcomes (1)

  • cancer-specific survival

    three years after surgery

Study Arms (2)

Blank control

NO INTERVENTION

do not use prophylactic intravesical chemotherapy.

Single intravesical instillation

EXPERIMENTAL

intravesical instillation within 24 hours postoperatively

Drug: Pirarubicin

Interventions

PirarubicinDRUG

single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of nephroureterectomy.

Single intravesical instillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected UTUC patients without history of bladder tumor.
  • Suspected UTUC patients without synchronous bladder tumor.
  • Suspected UTUC patients without contralateral UTUCs.

You may not qualify if:

  • Patients with history of bladder tumor.
  • Patients with synchronous bladder tumor.
  • Patients with contralateral UTUCs.
  • Patients with advanced stage (T4).
  • Patients with other malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Frist Hospital

Beijing, Beijing Municipality, 10034, China

RECRUITING

MeSH Terms

Interventions

pirarubicin

Central Study Contacts

Xuesong LI, M.D.

CONTACT

8601083572481

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

October 1, 2016

First Posted

October 4, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2021

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

CN(1)