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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007297


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name