UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000093
Receipt number R000000141
Scientific Title Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III)
Date of disclosure of the study information 2005/08/30
Last modified on 2014/06/24 16:16:34

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Basic information

Public title

Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III)

Acronym

Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III)

Scientific Title

Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III)

Scientific Title:Acronym

Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III)

Region

Japan


Condition

Condition

T2-T4aN0M0 invasive bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate clinical benefit of neoadjuvant MVAC chemotherapy in patients with invasive bladder cancer who are treated by radical cystectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

overall survival

Key secondary outcomes

non-progression survival, postoperative morbidity, adverse events of chemotharapy, rate of non-pathological residual disease of the bladder, and QOL


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 Maneuver

Interventions/Control_1

A:radical cystectomy alone

Interventions/Control_2

B:neoadjuvant MVAC chemotharapy + radical cystectomy

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) T2-T4aN0M0 invasive bladder cancer without prostatic stromal invasion that satisfied all the criteria shown below(1)invasive urothelial cancer with definite muscle-invasion or more extention that is clearly proven with pathological examination of TUR specimens (2)both lymph node nd distant metastases with image diagnosis (N0M0)
2) No simultaneous diagnosis or suspision of urothelial cancer in the urinary tract other than the bladder at the time of initial diagnosis of invasiv bladder cancer
3) No previous treatment for invasive bladder cancer
4) No previous surgery (other than TUR-Bt), systemic or intra-arterial chemotherapy or radiation for superficial bladder cancer
5) No previous chemotherapy or radiation for other cancers or diseases
6) No previous history of urothelial cancer other than superfical bladder cancer
7) No later than 8 weeks after TUR-Bt
8) patients with 20 years old or older, or 75 years old or youger
9) patients with PS 0-1
10) adewuate preservation of organ function
11) written informed consent provided

Key exclusion criteria

patients who meet one of criteria below are excluded.
1) active cancer simultaneously occurred in organs other than the urinary tract
2) women who are pregnant, possibly pregnant or lactating
3) patients with psychological disorders or symptoms
4) patients who has recived systemic steroid treatment
5) serious comorbiditirs
IHD or arrythemia that should be reated
history of myocarddial infarction occured within 6 months
liver cirrhosis
interstitial pneumonitis, pulmonary fibrosis, or repiratory diseases
needing O2 inhalation
uncontrolable diabetes
6) patients inapprppriate for the study entry determined by a doctor

Target sample size

360


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taiji Tsukamoto, MD, D.Med.Sci

Organization

Sapporo Medical University School of Medicine

Division name

Department of Urology

Zip code


Address

Minami-1Jo, Nishi-16, Chuo-Ku, Sapporo 060-8543,JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Naoya Masumori, MD

Organization

JCOG0209 Coordinating Office

Division name

Department of Urology, Sapporo Medical University School of Medicine

Zip code


Address

Minami-1Jo, Nishi-16, Chuo-Ku, Sapporo 060-8543,JAPAN

TEL


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

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)
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)
筑波大学臨床医学系(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)
千葉大学医学部(千葉県)
国立がんセンター中央病院(東京都)
慶應義塾大学病院(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)
北里大学医学部(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)
日本赤十字社和歌山医療センター(和歌山県)
島根大学医学部(島根県)
倉敷中央病院(岡山県)
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)
国立病院機構九州がんセンター(福岡県)
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)
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

2005 Year 08 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24669010

Number of participants that the trial has enrolled


Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

Completed

Date of protocol fixation

2003 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2003 Year 06 Month 01 Day

Last follow-up date

2014 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 08 Month 30 Day

Last modified on

2014 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000141


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name