search
Back to results

Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

Primary Purpose

Intravesical Instillation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pirarubicin(THP)
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intravesical Instillation focused on measuring urothelial cancer, bladder cancer, nephroureterectomy

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long-term Intravesical Instillation of pirarubicin(THP)

Single Intravesical Instillation of pirarubicin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
questionnaire for quality of life
e.g QLQ C-30
progression-free survival
progression-free survival
cancer-specific survival
cancer-specific survival
overall survival
overall survival

Full Information

First Posted
January 17, 2017
Last Updated
October 7, 2019
Sponsor
RenJi Hospital
Collaborators
Shanghai Pudong Hospital, Shanghai Pudong New Area Gongli Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03030157
Brief Title
Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma
Official Title
Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai Pudong Hospital, Shanghai Pudong New Area Gongli Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravesical Instillation
Keywords
urothelial cancer, bladder cancer, nephroureterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-term Intravesical Instillation of pirarubicin(THP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Single Intravesical Instillation of pirarubicin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
pirarubicin(THP)
Primary Outcome Measure Information:
Title
The incidence of bladder cancer in the first 12 month following nephroureterectomy
Description
Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
2 day, 1 month and 12 month
Title
questionnaire for quality of life
Description
e.g QLQ C-30
Time Frame
baseline, 1 month and 12 month
Title
progression-free survival
Description
progression-free survival
Time Frame
12 month
Title
cancer-specific survival
Description
cancer-specific survival
Time Frame
12 month
Title
overall survival
Description
overall survival
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinically diagnosed with upper tract urothelial carcinoma have no distant metastasis have an ECOG 0 to 2 expected to receive radical nephroureterectomy Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jiwei huang
Phone
8613651682825
Email
jiweihuang@outlook.com
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiwei huang, M.D
Phone
8613651682825
Email
jiweihuang@outlook.com
First Name & Middle Initial & Last Name & Degree
jin zhang
Phone
86-21-68383776
Email
zhangjin@renji.com

12. IPD Sharing Statement

Learn more about this trial

Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

We'll reach out to this number within 24 hrs