NCT03030157

Brief Summary

Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2017

Typical duration 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

Study Start

First participant enrolled

January 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

January 17, 2017

Last Update Submit

October 7, 2019

Conditions

Intravesical Instillation

Keywords

urothelial cancerbladder cancernephroureterectomy

Outcome Measures

Primary Outcomes (1)

  • The incidence of bladder cancer in the first 12 month following nephroureterectomy

    Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.

    12 month

Secondary Outcomes (5)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    2 day, 1 month and 12 month

  • questionnaire for quality of life

    baseline, 1 month and 12 month

  • progression-free survival

    12 month

  • cancer-specific survival

    12 month

  • overall survival

    12 month

Study Arms (2)

Long-term Intravesical Instillation of pirarubicin(THP)

EXPERIMENTAL

A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The first instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.

Drug: pirarubicin(THP)

Single Intravesical Instillation of pirarubicin

ACTIVE COMPARATOR

A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.

Drug: pirarubicin(THP)

Interventions

pirarubicin(THP)DRUG
Long-term Intravesical Instillation of pirarubicin(THP)Single Intravesical Instillation of pirarubicin

Eligibility Criteria

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

You may qualify if:

  • clinically diagnosed with upper tract urothelial carcinoma
  • have no distant metastasis
  • have an ECOG 0 to 2
  • expected to receive radical nephroureterectomy

You may not qualify if:

  • a prior history of bladder or synchronous bladder cancer
  • administration of neoadjuvant chemotherapy
  • the presence of severe complications
  • deny to receive cytoscopy
  • patients with advanced stage (T4)
  • patients with contralateral UTUCs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

pirarubicin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

jiwei huang

CONTACT

8613651682825jiweihuang@outlook.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Urology department in Renji Hospital

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 24, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations

CN(1)