UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007787
Receipt No. R000009175
Scientific Title 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
Date of disclosure of the study information 2012/04/19
Last modified on 2016/12/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym EXPERT
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Norihiro Kokudo
Organization The University of Tokyo
Division name Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Hasegawa, Masaru Oba
Organization The University of Tokyo
Division name Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol http://www.ibri-kobe.org/
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 No longer recruiting
Date of protocol fixation
2012 Year 02 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.