UMIN-CTR Clinical Trial

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
Email	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/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007297