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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001861
Receipt No. R000002241
Scientific Title A randomized competitive trial of BCG instillation therapy with UFT for prevention of superficial bladder cancer recurrence.
Date of disclosure of the study information 2009/05/01
Last modified on 2009/04/08

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Basic information
Public title A randomized competitive trial of BCG instillation therapy with UFT for prevention of superficial bladder cancer recurrence.
Acronym BCG+UFT therapy for superficial bladder cancer
Scientific Title A randomized competitive trial of BCG instillation therapy with UFT for prevention of superficial bladder cancer recurrence.
Scientific Title:Acronym BCG+UFT therapy for superficial bladder cancer
Region
Japan

Condition
Condition Bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to verify the effectiveness of UFT for prevention of superficial bladder cancer recurrence.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Duration of recurrence free survival within 3 years.
Key secondary outcomes Safety
QOL investigation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bladder instillation therapy of BCG.
Interventions/Control_2 Bladder instillation therapy of BCG.
+ UFT (400mg/day as tegefur)
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)Bladder cancer
2)Pathological diagnosis ; transitional cell carcinoma. TNM classification ; Ta&G3, T1&G2, T1&G3, accompanying CIS, multifocal, cases with recurrence.
*The cases of recurrence who did not receive BCG or UFT prior to this study can be included, regardless; number of tumors, Ta&G1, Ta&G2, T1&G1.
3)20 to 79 years old at diagnosis.
4)Performance status (ECOG) of the cases should be 0 or 1.
5)Function of important organ should be sufficient.
6)Tolerable for internal use for UFT.
7)Inspection value standard
3000/mm3 <= WBC < 12,000/mm3
Neutrophile ;1,500/mm3<=
Platelet ;100,000/mm3<=
sGOT/sGPT ; Within twice of normal range in respective institutes.
sT-bilirubin; <1.5mg/dl
Hb; =>9.0g/dls
Creatinin; <1.5mg/dl
8) Agreement form for this study should be obtained from the patients.
Key exclusion criteria 1) TNM classification; Ta&G1, Ta&G2, T1&G1,initial, single, primary CIS.
2) Prior therapy of BCG and/or UFT.
3) Prior therapy of irradiation.
4) Presence of active other cancers.
5) Having a severe complications occurred within 3 months before this study; serious heart disease, severe hypertension, severe diabetes, severe angina, ileus, interstitial-Pneumonitis, lung fibrosis, heart failure, renal failure, liver dysfunction, severe infection.
6) HIV patient, need of steroid therapy.
7) Strong positivity for tuberculin test.
8) Presence of water severe diarrhea.
9) Contraindications for BCG or UFT.(According to attached files of BCG or UFT.)
10) Presence of severe allergy for medicines.
11) A pregnant women, a woman of breast-feeding, a woman who want to get pregnant.
12) A man who want to make pregnant.
Target sample size 354

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Ogawa
Organization Showa University
Division name Urology
Zip code
Address 1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan.
TEL 03-3784-8560
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun Morita
Organization Showa University
Division name Urology
Zip code
Address 1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan.
TEL 03-3784-8560
Homepage URL
Email moritajun@hotmail.co.jp

Sponsor
Institute Study Group of Urothelial Cancer
Kitasato institute hospital
Kitasato University
Kyorin University
Keio University
Showa University
Teikyo University
Tokyo Medical University
Jikei University
Toho University
Institute
Department

Funding Source
Organization None
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
2009 Year 05 Month 01 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
2009 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
2015 Year 05 Month 01 Day
Date trial data considered complete
2015 Year 08 Month 01 Day
Date analysis concluded
2015 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 08 Day
Last modified on
2009 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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