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
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
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
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
