UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007787 |
|---|---|
| Receipt number | 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 22:56:03 |
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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
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/
expert-office@umin.org
Sponsor or person
Institute
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009175
