UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010429
Receipt No. R000012125
Scientific Title An exploratory study to evaluate biomarkers as predictive and /or prognostic factors of benefit from randomized phase ll study of mFOLFOX6+bevacizumab or mFOLFOX6+cetuximab in liver only metastasis from KRAS wild type colorectal cancer
Date of disclosure of the study information 2013/04/05
Last modified on 2019/10/10 (Ver. 15)

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Basic information
Public title An exploratory study to evaluate biomarkers as predictive and /or prognostic factors of benefit from randomized phase ll study of mFOLFOX6+bevacizumab or mFOLFOX6+cetuximab in liver only metastasis from KRAS wild type colorectal cancer
Acronym Exploratory study in achievement of improved survival by molecular targeted chemotherapy and liver resection for not optimally resectable colorectal liver metastases
Scientific Title An exploratory study to evaluate biomarkers as predictive and /or prognostic factors of benefit from randomized phase ll study of mFOLFOX6+bevacizumab or mFOLFOX6+cetuximab in liver only metastasis from KRAS wild type colorectal cancer
Scientific Title:Acronym Exploratory study in achievement of improved survival by molecular targeted chemotherapy and liver resection for not optimally resectable colorectal liver metastases
Region
Japan

Condition
Condition liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS); centrally assessed
Key secondary outcomes 1) To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events

- Response rate (RR)
- Tumor shrinkage rate at week 8
- Liver resection rate
- R0 liver resection rate (patholigically confirmed)
- Progression-free survial (PFS); CT/MRI image assessed by the attending physician
- Time to treatment-failure (TTF)
- Overall survival (OS)
- Incidence of adverse events (drag-related, surgery-related)
- Exploratory endpoints
- Primary endpoint and secondary endpoints in the RAS wild-type subpopulation
2) Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 mFOLFOX6 + bevacizumab
Interventions/Control_2 mFOLFOX6 + cetuximab
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 months-old <=
Age-upper limit
80 months-old >=
Gender Male and Female
Key inclusion criteria Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichinosuke Hyodo / Yoshihiro Kakeji
Organization Graduate School of Comprehensive Human Sciences, Tsukuba University / Kobe University Graduate School of Medicine
Division name Department of Gastroenterology / Division of Gastrointestinal Surgery, Department of Surgery
Zip code
Address 2-1-1 Amakubo, Tsukuba, 305-8576, Japan / 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, Japan
TEL 03-5684-7767
Email prj-atomdc@eps.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name EPS Corporation
Organization EPS Corporation
Division name CRO Company Clinical Information Division
Zip code
Address 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, 162-0814, Japan
TEL 03-5684-7767
Homepage URL
Email prj-atomdc@eps.co.jp

Sponsor
Institute EPS Corporation
Institute
Department

Funding Source
Organization CHUGAI PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization Other
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 YES
Study ID_1 NCT01834014
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions <北海道>
函館五稜郭病院
北海道大学病院
市立札幌病院
釧路労災病院
<青森>
弘前大学医学部附属病院
<宮城>
石巻赤十字病院
東北大学病院
<秋田>
大曲厚生医療センター
<山形>
公立置賜総合病院
<福島>
いわき市立総合磐城共立病院
<茨城>
日立総合病院
土浦協同病院
茨城県立中央病院
筑波大学附属病院
水戸医療センター
<群馬>
群馬県立がんセンター
<千葉>
帝京大学ちば総合医療センター
千葉県がんセンター
国保旭中央病院
<東京>
東邦大学医療センター大森病院
東京医科歯科大学医学部附属病院
東京女子医科大学
都立駒込病院
<神奈川>
横須賀市立うわまち病院
昭和大学藤が丘病院
横浜市立大学附属病院
昭和大学横浜市北部病院
<新潟>
新潟県立がんセンター新潟病院
<石川>
金沢赤十字病院
石川県立中央病院
<福井>
福井県済生会病院
福井県立病院
福井大学医学部附属病院
<岐阜>
朝日大学歯学部附属村上記念病院
松波総合病院
岐阜大学
<静岡>
聖隷浜松病院
浜松医療センター
<愛知>
名古屋市立大学
愛知県がんセンター中央病院
名古屋医療センター
半田市立半田病院
<三重>
三重大学医学部附属病院
<滋賀>
滋賀県立成人病センター
大津市民病院
<京都>
京都桂病院
京都大学医学部附属病院
<大阪>
大阪医科大学附属病院
済生会中津病院
近畿大学
<兵庫>
佐野病院
神戸医療センター
姫路赤十字病院
兵庫医科大学
神戸市立医療センター中央市民病院
神戸大学
西神戸医療センター
兵庫県立西宮病院
明和病院
<岡山>
岡山大学病院
<広島>
中国中央病院
県立広島病院
広島大学
<山口>
下関医療センター
山口大学医学部附属病院
<徳島>
徳島大学病院
<香川>
香川大学医学部附属病院
<愛媛>
四国がんセンター
松山赤十字病院
<福岡>
久留米大学
飯塚病院
九州中央病院
久留米大学医療センター
済生会福岡総合病院
JCHO九州病院
九州大学
九州医療センター
北九州総合病院
九州がんセンター
製鉄記念八幡病院
<佐賀>
佐賀大学医学部附属病院
<長崎>
佐世保市立総合病院
長崎大学
<熊本>
熊本大学
済生会熊本病院
<大分>
別府医療センター
大分赤十字病院
<鹿児島>
鹿児島大学
<沖縄>
中頭病院
那覇市立病院
琉球大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 05 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
2013 Year 03 Month 05 Day
Date of IRB
2013 Year 02 Month 28 Day
Anticipated trial start date
2013 Year 05 Month 07 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 05 Day
Last modified on
2019 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012125