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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008473
Receipt No. R000009965
Scientific Title Phase II study of cetuximab with mFOLFOX6 therapy in patients with KRAS wild-type advanced colorectal cancer which has unresectable liver metastases
Date of disclosure of the study information 2012/07/23
Last modified on 2020/01/28

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Basic information
Public title Phase II study of cetuximab with mFOLFOX6 therapy in patients with KRAS wild-type advanced colorectal cancer which has unresectable liver metastases
Acronym Cmab mFOLFOX6 study
Scientific Title Phase II study of cetuximab with mFOLFOX6 therapy in patients with KRAS wild-type advanced colorectal cancer which has unresectable liver metastases
Scientific Title:Acronym Cmab mFOLFOX6 study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate antitumor effect, safety and efficacy of cetuximab with mFOLFOX6 therapy inpatients with KRAS wild-type advanced colorectal cancer which has unrecectable liver metastasis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Safety
Resection rate of liver metastatis resion
R0 liver resection rate
Relapse-free survival
Overall survival
Treatment completion rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The initial dosage of Cetuximab assumes it 400mg/ m2.
Cetuximab gives the second one week after initial administration, but the dose from the second assumes it 250mg/ m2.
mFOLFOX6 repeats the administration once in two weeks to up to six courses as 1 course.
Cetuximab is given in day 1 and day 8 all over the course of mFOLFOX6.
Perform hepatectomy four weeks later from the next day on a chemotherapy end day in case of resectable at the end of chemotherapy of 6 curses.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Colorectal cancer histological proven
2)Unresectable liver metastasis more than 5 synchronism liver metastases or more than 5cm tumor size
3)Primary tumor is performed radical excision of; or the case that is available for radical excision in curative hepatectomy by this study and synchronism or heterochrony
4)KRAS wild type of Codon 12 and codon 13
5)A measurable lesion or an evaluable lesion is confirmed with an objectivity document according to RECIST standard
6)No prior chemotherapy for colorectal cancer
7)No prior oxaliplatin and cetuximab or panitumumab
8)More than 20 years old
9)Expect to survive more than 3 months
10)ECOG performance status: 0-1
11)Organs (bone marrow, lung, liver and kidney) failure is not advanced
i)Hemoglobin : more than 8.0g/dl
ii)Neutrophil count : more than 1,500 / mm3
iii)Platelet : more than 100,000 / mm3
iv)Serum total bilirubin : less than 1.5 mg / dl
v)AST,ALT : less than 200 U/l
vi)Serum creatinine : less tahn 1.5 mg / dl
12)ECG no abnormalities in 28 days before
13)Informed consent
Key exclusion criteria 1)Severe drug allergy
2)Metastatic focus out of the liver
3)Active double cancer
4)Active infection
5)Intestinal paralysis, intestinal obstruction
6)Severe complications (interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure, it is difficult to control hypertention, diabetes etc.)
7)Pleural effusion, ascites
8)Diarrhea (watery stool)
9)Brain metastases
10)Pregnant and lacting women
11)A bleeding tendency, coagulation disorder or the case with the abnormal clotting factor
12)Mental disorder
13)Patients who receive steroid continuously are excluded
14)Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded
15)History of the organ transplantation to need an immunosuppressive drug
16)The patient that a study responsibility physician judged to be inappropriat
Target sample size 23

Research contact person
Name of lead principal investigator
1st name Ayumu
Middle name
Last name Goto MD. PhD.
Organization Yokohama City University Hospital
Division name Clinical Oncology division
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email ayumu16g@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Ayumu
Middle name
Last name Goto MD. PhD.
Organization Yokohama City University Hospital
Division name Clinical Oncology division
Zip code 232-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email ayumu16g@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital Clinical Oncology division
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 Yokohama City University Ethics Committee
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
Tel 0453707627
Email rinri@yokohama-cu.ac.jp

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 横浜市立大学附属病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立市民病院(神奈川県)
伊東市民病院(静岡県)
横浜掖済会病院(神奈川県)
横浜市済生会南部病院(神奈川県)
済生会若草病院(神奈川県)
横浜船員保険保険病院(神奈川県)
藤沢市民病院(神奈川県)
横須賀共済病院(神奈川県)
横須賀市立市民病院(神奈川県)
独立行政法人国立病院機構横浜医療センター(神奈川県)
横浜市立みなと赤十字病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 23 Day

Related information
URL releasing protocol NONE
Publication of results Unpublished

Result
URL related to results and publications NONE
Number of participants that the trial has enrolled 7
Results
early termination of clinical trial because of less saple size
Results date posted
2020 Year 01 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
single arm phase II trial of mFOLFOX6 plus cetuximab for colorectal cancer patients with liver metastasis
Participant flow
Single arm phase II (no randomaization)
Adverse events
No severe adverse events
Outcome measures
This single arm hase II trial has Simon Two-Stage design (Optimal design)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 10 Month 13 Day
Date of IRB
2011 Year 11 Month 10 Day
Anticipated trial start date
2012 Year 07 Month 23 Day
Last follow-up date
2018 Year 01 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
2012 Year 07 Month 19 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009965

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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