UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001861 |
|---|---|
| Receipt number | 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 17:25:46 |
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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
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
moritajun@hotmail.co.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.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 |
