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 |
* 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
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/
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
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
