UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

overall response rate

Key secondary outcomes

R0 resection rate, safety, DFS, OS

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

eiji.shinozakii@jfcr.or.jp

Institute

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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