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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007545
Receipt No. R000008888
Scientific Title Feasibility study of neoadjuvant mFOLFOX6 plus cetuximab in patients with resectable liver limited metastases from colorectal cancer harboring KRAS wild type
Date of disclosure of the study information 2012/03/21
Last modified on 2015/04/22

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Basic information
Public title Feasibility study of neoadjuvant mFOLFOX6 plus cetuximab in patients with resectable liver limited metastases from colorectal cancer harboring KRAS wild type
Acronym FANTASTIC trial
Scientific Title Feasibility study of neoadjuvant mFOLFOX6 plus cetuximab in patients with resectable liver limited metastases from colorectal cancer harboring KRAS wild type
Scientific Title:Acronym FANTASTIC trial
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of neoadjuvant chemotherapy and surgery (hepatectomy) for colorectal cancer with resectable liver metastases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Treatment completion rate
Key secondary outcomes Safety(CTCAE ver4.0), RR, Liver resectability, R0 rate, Postoperative complications, Explore the appropriate treatment duration from ICG (after 4 and 6 course) and CT

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 mFOLFOX6 + cetuximab
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)Patients with histologically proven colorectal cancer
(2)Resectable synchronous and metachronous liver metastases
(3)Metastatic colorectal cancer with EGFR expressed
(4)KRAS wild type in codon 12, 13
(5)Age over 20 years
(6)ECOG Performance Status (PS) 0-1
(7)Presence of measurable lesion (RECIST Ver.1.1)
(8)No prior chemotheray
(9)Patiens have enough organ function for study treatment
(10)Life expectancy of more than 3 months
(11)Written informed consent
Key exclusion criteria (1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
(2)Symptomatic brain metastases
(3)Severe infectious disease
(4)Interstitial lung disease or pulmonary fibrosis
(5)Comorbidity or history of heart failure
(6)Sensory alteration or paresthesia interfering with function
(7)Severe comorbidity (renal failure, liver failure, hypertension, etc)
(8)History of severe allergy
(9)Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Yoshino
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code
Address 6-5-1 Kashiwanohara, Kashiwa, Chiba
TEL 04-7133-1111
Email tyoshino@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Bando
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code
Address 6-5-1 Kashiwanohara, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email hbando@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 21 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 Terminated
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2014 Year 11 Month 22 Day
Date of closure to data entry
2014 Year 11 Month 28 Day
Date trial data considered complete
2014 Year 11 Month 28 Day
Date analysis concluded
2014 Year 11 Month 28 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 21 Day
Last modified on
2015 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008888

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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