UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004378
Receipt number R000005234
Scientific Title A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer
Date of disclosure of the study information 2010/10/21
Last modified on 2015/04/13 17:17:44

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer

Acronym

A single immediate postoperative prophylactic intravesical instillation of Pirarubicin for non-muscle invasive bladder cancer

Scientific Title

A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer

Scientific Title:Acronym

A single immediate postoperative prophylactic intravesical instillation of Pirarubicin for non-muscle invasive bladder cancer

Region

Japan


Condition

Condition

non-muscle invasive bladder cancer (pTa and low grade)

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Clinical investigation of efficacy of a single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of low-risk non-muscle invasive bladder cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Duration of recurrence-free survival

Key secondary outcomes

Two-year recurrence free survival rate
Safty


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Immediate intravesical instillation of Pirarubicin 30 mg following transurethral resection of bladder cancer

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) non-muscle invasive bladder cancer (pTa and low grade).
(2) Curative resection of all visible tumor can be performed.
(3) non-muscle invasive bladder cancer without any CIS element
(4) Function of all organs are within normal range
(5) ECOG performance status, 0-2

Key exclusion criteria

(1) patients with duplex of active other malignant disease.
(2) Patients with history or present disease of upper urinary tract utotherial carcinoma.
(3) Patients with severe disfunction of renal, liver, hematopoietic or heart.
(4) Patients with history of allergic reaction against doxorubicin or epirubicin

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masato Fujisawa

Organization

Kobe University Graduate School of Medicine

Division name

Division of Urology

Zip code


Address

7-5-1, Kusunoki-cho, Kobe

TEL

078-382-6155

Email

uro6155@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Miyake

Organization

Kobe University Graduate School of Medicine

Division name

Division of Urology

Zip code


Address

7-5-1, Kusunoki-cho, Kobe

TEL

078-382-6155

Homepage URL


Email

hideakimiyake@hotmail.com


Sponsor or person

Institute

Kobe University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

神戸大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2010 Year 10 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2010 Year 10 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date

2014 Year 10 Month 01 Day

Date of closure to data entry

2016 Year 03 Month 01 Day

Date trial data considered complete

2016 Year 03 Month 01 Day

Date analysis concluded

2017 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 10 Month 13 Day

Last modified on

2015 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005234


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name