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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005381
Receipt No. R000006386
Scientific Title Neoaduvant chemotherapy woth FOLFOXIRI and anti-EGFR monoclonal antibody for colorectal cancer with liver metastasis
Date of disclosure of the study information 2011/04/07
Last modified on 2012/04/06

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Basic information
Public title Neoaduvant chemotherapy woth FOLFOXIRI and anti-EGFR monoclonal antibody for colorectal cancer with liver metastasis
Acronym Neoaduvant chemotherapy woth FOLFOXIRI and anti-EGFR monoclonal antibody for colorectal cancer with liver metastasis
Scientific Title Neoaduvant chemotherapy woth FOLFOXIRI and anti-EGFR monoclonal antibody for colorectal cancer with liver metastasis
Scientific Title:Acronym Neoaduvant chemotherapy woth FOLFOXIRI and anti-EGFR monoclonal antibody for colorectal cancer with liver metastasis
Region
Japan

Condition
Condition colorectal cancer with liver metastasis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study was efficasy of FOLFOXIRI+anti-EGFR monoclonal antibody for liver metastasis of colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes R0 rejective rate
Key secondary outcomes Safety

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 day1:CPT-11(150mg/m2),L-OHP(65mg/m2),L-LV(200mg/m2)
day1-2:5-FU(3200mg/m2)48hr civ,
day1:Panitumumab(6mg/kg)
or day1 and 7 cetuximab(400mg/m2)
ever 2 weeks
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)histlogically colorectal adenocarcinoma and KRAS mutation status was wildtype
2)without primary surgery chemotherapy radiotherapy
3)within liver metastasis
4)a)age 20-
b)PS(ECOG)0-1
c)without interstitinal lung fibrosis
d)adequate organ function,14 days before entry
hemoglobin:>9.0g/dl
leukocyte count:>3000-12000/mm3
neutrophl cell count:>1500/mm3
serum bilirubin level <1.5mg/dl
AST,ALT:<200U/I
serum creatinine level:<1.2mg/dl
estimate creatinine clearance level:>60ml/min
nomal ECG within 28days before entry
5)written informed consent from patients
Key exclusion criteria 1)had a previous serious medical illness or allergy for drugs
2)had active double cancer
3)had a hypersensitivity or taboo for test drugs
4)had active infection disease(oner 38.0C fever)
5)had serious complication(ireus,renal function,liver function,heart failure,diabetes within could not control)
6)had serious bowel blockage
7)had serious interstitinal fibrosis
8)had pleural effusion or abdominal dropsy within could not control
9)had watersolubility diarrhea
10)had brain metastasis
11)pregnant or lactating woman,woman who are capable of pregnancy or intend to get pregnant,man who are not inend to contraception
12)had mental illness
13)expect referred to above physician in charge of this trial gave a diagnosis the patient who can not join this trial for the safety
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Shimada
Organization Tokushima university
Division name Department of surgery and transplantation
Zip code
Address 3-18-15 Kuramoto,Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima university
Division name Department of surgery and transplantation
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Tokushima university
Institute
Department

Funding Source
Organization Department of surgery and transplantation
Tokushima university
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

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 07 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 Preinitiation
Date of protocol fixation
2011 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2014 Year 03 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
2011 Year 04 Month 05 Day
Last modified on
2012 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006386

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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