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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001396
Receipt No. R000001698
Scientific Title Randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer
Date of disclosure of the study information 2008/09/26
Last modified on 2016/10/12

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Basic information
Public title Randomized phase III study of FOLFOX plus bevacizumab versus
FOLFIRI plus bevacizumab for metastatic colorectal cancer
Acronym Randomized phase III study of bevacizumab containing chemotherapy for metastatic colorectal cancer
Scientific Title Randomized phase III study of FOLFOX plus bevacizumab versus
FOLFIRI plus bevacizumab for metastatic colorectal cancer
Scientific Title:Acronym Randomized phase III study of bevacizumab containing chemotherapy for metastatic colorectal cancer
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare combination chemotherapy of bevacizumab plus FOLFOX with combination chemotherapy of bevacizumab plus FOLFIRI in patients with metastatic colorectal cancer.
Basic objectives2 Others
Basic objectives -Others Progression free survival, Overall survival, Time to treatment failure, Response rate, R0 resection rate, Toxicity, Quality of life
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival, Time to treatment failure, Response rate, R0 resection rate, Toxicity, Quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FOLFOX plus bevacizumab
Interventions/Control_2 FOLFIRI plus bevacizumab
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.Histologically documented metastatic measurable adenocarcinoma of the colorectum with no prior chemotherapies for metastatic disease.
2.Age: >20, <75.
3.ECOG PS of 0 or 1.
4.Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters.
5.Written informed consent.
Key exclusion criteria 1.Brain metastasis with symptoms.
2.Massive asites, pleural effusion or pericardial effusion.
3.Double cancer with in five years prior to enroll in this study.
4.Serious non-healing wound.
5.Major surgical procedure within 28 days prior to enroll in this study.
6.Minor surgical procedure within 14 days prior to enroll in this study.
7.Other serious concomitant disease.
8.Regular use of corticosteroid.
9.Regular use of anticoagulation therapy.
10.Peripheral neuropathy > Grade 1 at baseline.
11.Active infectious disease.
12.History of serious hypersensitivity.
13.Hepatitis B surface antigen.
14.Mental disorder.
15.Pregnant or nursing.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Yamazaki
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology and Endoscopy
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan
TEL 055-989-5222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 静岡県立静岡がんセンター(静岡県)
兵庫県立淡路病院(兵庫県)
自治医科大学(栃木県)
健生会 土庫病院(奈良県)
宮崎大学附属病院(宮崎県)
独立行政法人国立病院機構 九州がんセンター(福岡県)
九州大学病院(福岡県)
独立行政法人国立病院機構 四国がんセンター(愛媛県)
大阪市立総合医療センター(大阪府)
筑波大学附属病院(茨城県)
KKR札幌医療センター 斗南病院(北海道)
地方独立行政法人大阪府立病院機構 大阪府立成人病センター(大阪府)
栃木県立かんセンター(栃木県)
市立釧路総合病院(北海道)
龍ヶ崎済生会病院(茨城県)
大阪医科大学附属病院(大阪府)
近畿大学医学部堺病院(大阪府)
愛知県がんセンター中央病院(愛知県)
帝京大学医学部付属病院(東京都)
聖マリアンナ医科大学病院(神奈川県)
地方独立行政法人大阪府立病院機構 大阪府立呼吸器・アレルギー医療センター(大阪府)
高知医療センター(高知県)
近畿大学医学部附属病院(大阪府)
近畿大学医学部奈良病院(奈良県)
熊本地域医療センター(熊本県)
札幌医科大学附属病院(北海道)
新潟県立がんセンター新潟病院(新潟県)
富山大学医学部(富山県)
東海大学医学部付属病院(神奈川県)
大阪府立急性期・総合医療センター(大阪府)
横浜市立市民病院(神奈川県)
独立行政法人国立病院機構 北海道がんセンター(北海道)
神戸大学医学部附属病院(兵庫県)
独立行政法人国立病院機構 岡山医療センター(岡山県)
市立吹田市民病院(大阪府)
県立広島病院(広島県)
徳島大学病院(徳島県)
兵庫県立がんセンター(兵庫県)
名古屋共立病院(愛知県)
市立室蘭総合病院(北海道)
群馬大学大学院(群馬県)
済生会宇都宮病院(群馬県)
NTT東日本関東病院(東京都)
倉敷中央病院(岡山県)
愛媛県立中央病院(愛媛県)
亀田総合病院(千葉県)
千葉県がんセンター(千葉県)
癌研究会有明病院(東京都)
名古屋市立大学病院(愛知県)
岡山赤十字病院(岡山県)

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27177863
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 Completed
Date of protocol fixation
2008 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2015 Year 02 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
2008 Year 09 Month 26 Day
Last modified on
2016 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001698

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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