UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005381 |
|---|---|
| Receipt number | 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 08:09:53 |
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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
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
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006386
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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