UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007545 |
|---|---|
| Receipt number | 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 21:34:16 |
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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
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
hbando@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008888
