UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004811 |
|---|---|
| Receipt number | R000005720 |
| Scientific Title | mFOLFOX6+Cetuximab in Treating Patients With not Optimally Resectable Liver Metastases From Colorectal Cancer |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2011/01/01 14:16:02 |
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Basic information
Public title
mFOLFOX6+Cetuximab in Treating Patients With not Optimally Resectable Liver Metastases From Colorectal Cancer
Acronym
mFOLFOX6+Cetuximab in Treating Patients With not Optimally Resectable Liver Metastases From Colorectal Cancer
Scientific Title
mFOLFOX6+Cetuximab in Treating Patients With not Optimally Resectable Liver Metastases From Colorectal Cancer
Scientific Title:Acronym
mFOLFOX6+Cetuximab in Treating Patients With not Optimally Resectable Liver Metastases From Colorectal Cancer
Region
| Japan |
Condition
Condition
liver metastases from colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Perioperative systemic chemotherapy is expected to improve the survival after liver metastase resection from colorectal cancer in especially technical resectable case with poor prognostic factors.
We conduct this trial to asses the safety and efficacy of mFOLFOX6+cetuximab for not optimally resectable liver metastases from colorectal cancer in KRAS wild type.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall response rate
Key secondary outcomes
R0 resection rate, safety, DFS, OS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mFOLFOX6Cetuximab
Neoadjuvant 6course
Adjuvant 6course
Cetuximab loading dose 400mg/m2
weekly 250mg/m2/week
LOHP 85mg/m2/day1
lLV 200mg/m2/day1
bolus 5FU 400mg/m2/day1
infusional 5FU 2400mg/m2/day1-3
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) histhopathological proven adenocarcinoma of colorectal cancer
2) liver metastases without extra hepatic metastases excep hilar LNs
3) marginal resectable defined following criteria
(i)maximum diameter >5cm
(ii)the number of liver metastases >4
(iii)primally N factor >N3
(iv)major vesseles invasion
4) No prior chemotherapy except adjuvant chemotherapy before more than 6 months
5) no prior treatment for liver metastases within 28 days of registration
6) 20 years old or older
7)ECOG Performance Status <2
8) adequate organ function following
(i)WBC=or>3,000/mm3
(ii)ANC=or>1,500/mm3
(iii)Plt=or>100,000/mm3
(iv)Hb=or>9.0g/dl
(v)AST (GOT), ALT (GPT)<5 times ULN
(vi)T-bil<1.5times ULN
(vii)Cre<ULN
9) measurable lesion in RECIST criteria
10) KRAS wild type
11) written IC form
Key exclusion criteria
1) No severe heart disease
2) No past history of AMI within 6 months
3) Not pregnant
4) Uncontrolled infectious disease
5) No systemic steroids or immunosupressant
6) No severe drug allergy
7) No psychological, familial, social, or geographical condition that would preclude study compliance
8) No symptomatic effusion collection
9) No severe peripheral neuropathy
10) No watery diarrhea
11) No other significant disease that would preclude study participationr
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Saiura |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Dept. of Gastroenterogical Surgery
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Shinozaki |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Dept. of Medical Oncology
Zip code
Address
TEL
Homepage URL
eiji.shinozakii@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
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
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 | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 01 | Day |
Last modified on
| 2011 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005720
