UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006390 |
|---|---|
| Receipt number | R000007297 |
| Scientific Title | Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII) |
| Date of disclosure of the study information | 2011/09/22 |
| Last modified on | 2021/01/06 13:37:03 |
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Basic information
Public title
Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII)
Acronym
Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII)
Scientific Title
Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII)
Scientific Title:Acronym
Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII)
Region
| Japan |
Condition
Condition
High grade T1 bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the non-inferiority of relapse-free survival (except Tis or Ta intravesical recurrence) of watchful waiting compared with intravesical BCG therapy for T0 in 2nd TUR after TURBT of high grade T1 bladder cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
relapse-free survival (except Tis or Ta intravesical recurrence)
Key secondary outcomes
overall survival, metastasis-free survival with bladder preserved, annual intravesical relapse-free survival rate, annual proportion of T2 or deeper relapse-free survival, adverse events, serious adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
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
A: BCG intravesical therapy (q1w, 8 courses)
Interventions/Control_2
B: watchful waiting
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
"First registration
1. Bladder tumor endoscopically resected completely by TURBT with fulfilling all of the followings histologically: i) high grade T1, ii) containing component of urothelial carcinoma, iii) containing component of tunica propria.
2. Aged 20 to 85 years old.
3. Within 56 days from the date of TURBT.
4. ECOG performance status (PS) of 0 or 1.
5. No history of administration of Cyclophosphamide and Methotrexate.
6. No history of irradiation for pelvic lesion.
7. No history of BCG intravesical therapy.
8. Neither history of bladder cancer except Tis, Ta bladder cancer nor history of upper urinary tract cancer(ureteral cancer and/or renal pelvic cancer).
9. Sufficient organ functions.
10. Not strongly positive for tuberculin reaction.
11. Written informed consent.
Second registration
1. Histologically proven T0 by 2nd TUR.
2. Negative or suspected positive in 2 consecutive urine cytology.
3. Within 28 days from the date of 2nd TUR.
4. Sufficient bone marrow functions.
5. No regional lymph node or distant metastasis examined by abdominopelvic CT or MRI.
Key exclusion criteria
First registration (no exclusion criteria at second registration)
1. Simultaneous or metachronous (within 5 years) double cancers.
2. Infectious disease (including tuberculosis) to be treated.
3. Body temperature of 38C or higher.
4. Positive anti-HIV antibody.
5. Women during pregnancy or breast-feeding.
6. Psychiatric diseases.
7. Systemic and continuous steroids medication.
8. History of severe brain ischemia or myocardial infarction within 6 months.
9. History of systemic anaphlactoid reaction for BCG.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Kakehi |
Organization
Kagawa University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan
TEL
087-891-2202
kakehi@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitamura |
Organization
JCOG1019 Coordinating Office
Division name
Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences. University of Toyama
Zip code
Address
2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
TEL
076-434-7372
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）
札幌医科大学（北海道）
函館厚生院函館五稜郭病院（北海道）
弘前大学医学部附属病院（青森県）
東北大学病院（宮城県）
宮城県立がんセンター（宮城県）
秋田大学医学部（秋田県）
山形大学医学部（山形県）
筑波大学医学医療系（茨城県）
栃木県立がんセンター（栃木県）
防衛医科大学校（埼玉県）
国立がん研究センター東病院（千葉県）
千葉大学医学部（千葉県）
国立がん研究センター中央病院（東京都）
東京慈恵会医科大学附属病院（東京都）
帝京大学医学部（東京都）
横浜市立大学附属市民総合医療センター（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
新潟大学医歯学総合病院（新潟県）
山梨大学医学部（山梨県）
信州大学医学部（長野県）
浜松医科大学（静岡県）
静岡県立静岡がんセンター（静岡県）
名古屋大学医学部（愛知県）
三重大学医学部（三重県）
京都大学医学部附属病院（京都府）
大阪大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
神戸大学医学部（兵庫県）
奈良県立医科大学（奈良県）
鳥取大学医学部（鳥取県）
島根大学医学部（島根県）
山口大学医学部附属病院（山口県）
香川大学医学部（香川県）
国立病院機構四国がんセンター（愛媛県）
久留米大学医学部（福岡県）
九州大学病院（福岡県）
原三信病院（福岡県）
熊本大学医学部（熊本県）
大分大学医学部附属病院（大分県）
宮崎大学医学部附属病院（宮崎県）
鹿児島大学医学部・歯学部附属病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007297
