UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of FOLFOX + Erbitux as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Title of the study (Brief title)	JACCRO CC-05 study
Region	Japan

Condition
Condition	Metastatic colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of cetuximab + FOLFOX as first line in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Overall Survival Progression Free Survival Safety Best response; % change at baseline

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 Cetuximab loading dose 400mg/sqm,250 mgsqm/week L-OHP 85 mg/sqm/biweekly Levofolinate 200 mg/sqm/biweekly 5-FU bolus 400 mg/sqm/biweekly 5-FU continuous 2,400 mg/sqm/biweekly
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients with histologically proven colorectal cancer 2.Metastatic colorectal cancer with EGFR expressed 3.KRAS wild type in codon 12, 13 4.Presence of measurable lesion (RECIST Ver.1.1) 5.no prior chemotherapy for unresectable primary tumor, metastases and lymph node metastasis. No primar therapy including surgery for recurrent that should be the first relapse after surgery for primary or metastases tumors 6.ECOG Performance Status(PS) 0-1 7.Age between 20 to 79 years 8.Life expectancy of more than 3 months 9.Patiens have enough organ function for study treatment 10.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.Large quantity of pleural, abdominal or cardiac effusion 8.Severe comorbidity (renal failure, liver failure, hypertension, etc) 9.Prior radiotherapy for primary and metastases tumors 10.Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 11.History of severe allergy 12.History of allergy for L-OHP and other platinating agent 13.Prior treatment of cetuximab or L-OHP 14.Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size	54

Research contact person
Name of lead principal investigator	Wataru Ichikawa
Organization	National Defense Medical College Hospital
Division name	Department of Clinical Oncology
Address	3-2 Namiki, Tokorozawa, Saitama, Japan, 359-8513
TEL	04-2995-1211
Email	wataru@ndmc.ac.jp

Public contact
Name of contact person	Wataru Ichikawa
Organization	National Defense Medical College Hospital
Division name	Department of Clinical Oncology
Address	3-2 Namiki, Tokorozawa, Saitama, Japan, 359-8513
TEL	04-2995-1211
Homepage URL
Email	wataru@ndmc.ac.jp

Sponsor
Institute	Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization	Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2010 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 21 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://link.springer.com/article/10.1007/s11523-016-0445-6
Results
Other related information

Management information
Registered date	2010 Year 09 Month 13 Day
Last modified on	2016 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005044