UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000093
Receipt No. 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

* 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 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
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

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
URL(English) https://upload.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


Contact us.