UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase III trial of surgery followed by mFOLFOX6 as adjuvant chemotherapy versus peri-operative mFOLFOX6 plus cetuximab for KRAS wild type resectable liver metastases of colorectal cancer
Title of the study (Brief title)	EXPERT
Region	Japan

Condition
Condition	Resectable colorectal liver metastases
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of surgery and peri-operative chemotherapy for metastatic colorectal cancer with resectable liver metastases as randomized phase lll trial
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival, Disease free survival, Safety, Postoperative complications, R0 rate, Liver resectability, Response rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Surgical hepatectomy followed by chemotherapy (mFOLFOX6) 12cycles. mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly)
Interventions/Control_2	Pre-operative chemotherapy(mFOLFOX6 plus cetuximab) 6cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6 plus cetuximab) 6cycles. Cetuximab(loading dose 400mg/m2, 250 mg/m2/week), mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly)
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) Patients with histologically proven colorectal cancer (2) Resectable synchronous and metachronous liver metastases (3) Metastatic colorectal cancer with EGFR expressed (4) KRAS wild type in codon 12, 13 (5) Age over 20 years (6) ECOG Performance Status(PS) 0-1 (7) Presence of measurable lesion in liver (RECIST Ver.1.1) (8) No prior chemotherapy for colorectal cancer (9) Patiens have enough organ function for study treatment (10) Life expectancy of more than 3 months (11) Written informed consent
Key exclusion criteria	(1) Extrahepatic metastases or history of extrahepatic metastases (2) Metachronous 1 liver metastasis (3) More than 9 liver metastases (4) Prior local therapy for liver metastases (5) Severe comorbidity (6) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (7) Severe infectious disease (8) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding . Women with a positive pregnancy test (9) Psychological disorder (10) Considered not appropriate for surgery
Target sample size	500

Research contact person
Name of lead principal investigator	Norihiro Kokudo
Organization	The University of Tokyo
Division name	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person	Kiyoshi Hasegawa, Masaru Oba
Organization	The University of Tokyo
Division name	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5800-8779
Homepage URL	http://www.ibri-kobe.org/
Email	expert-office@umin.org

Sponsor
Institute	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	2012 Year 04 Month 19 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 02 Month 29 Day
Anticipated trial start date	2012 Year 05 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	http://www.ibri-kobe.org/
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 19 Day
Last modified on	2016 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009175