UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005596
Receipt number R000006616
Scientific Title Group study of UFT following instillation of anticancer drug for superficial bladder cancer
Date of disclosure of the study information 2011/05/16
Last modified on 2015/12/24 20:38:53

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Basic information

Public title

Group study of UFT following instillation of anticancer drug for superficial bladder cancer

Acronym

GUARD study

Scientific Title

Group study of UFT following instillation of anticancer drug for superficial bladder cancer

Scientific Title:Acronym

GUARD study

Region

Japan


Condition

Condition

Non-muscle Invasive Bladder Cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of UFT as postoperative adjuvant therapy following TUR-Bt for non-muscle invasive bladder cancer compared with untreated control

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3 year recurrence-free survival

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment arm: Administration of oral UFT 400mg/day for 2 years

Interventions/Control_2

Control arm: No treatment

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Pathologically-proven non-muscle invasive bladder cancer after TUR-Bt with diagnosis of UC, Ta or T1, G1 or G2. Only primary cases are eligible.
2)Treated with immediate instillation of THP (20mg in 20ml saline) after TUR-Bt
3)20-79 year old
4)ECOG Performance Status of 0 or 1
5)Tolerable to oral UFT
6)Life expectancy of > 3 years
7)Reserved organ function
8)Patients who can start protocol therapy within 4 weeks after TUR-Bt
9)Written informed consent

Key exclusion criteria

1)Recurrent cancer
2)UC in prostatic urethra
3)History of previous therapy with UFT or systemic chemotherapy or pelvic radiotherapy
4)Serious comorbidity
5)Contraindication for UFT
6)Women who is pregnant or possibly pregnant
7)Any contraindication investigator specify

Target sample size

252


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Homma

Organization

University of Tokyo

Division name

Department of Urology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5800-8753

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Enomoto

Organization

University of Tokyo

Division name

Department of Urology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5800-8753

Homepage URL


Email

yenomoto-tky@umin.ac.jp


Sponsor or person

Institute

University of Tokyo, Department of Urology

Institute

Department

Personal name



Funding Source

Organization

N/A

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 16 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

Terminated

Date of protocol fixation

2011 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2015 Year 01 Month 20 Day

Date of closure to data entry

2015 Year 01 Month 20 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 05 Month 13 Day

Last modified on

2015 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name