Back to resultsExploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM ES)
Primary Purpose
Liver Metastasis, Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Bevacizumab
Cetuximab
L-OHP
l-LV
5-FU
5-FU
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastasis focused on measuring Liver only metastasis from KRAS Exon 2 wild type, Liver only metastasis from RAS wild type
Eligibility Criteria
Inclusion Criteria:
- Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.
Exclusion Criteria:
- None
Sites / Locations
- EPS Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mFOLFOX + Bmab
mFOLFOX + Cmab
Arm Description
mFOLFOX plus bevacizumab
mFOLFOX plus cetuximab
Outcomes
Primary Outcome Measures
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)
To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed
Secondary Outcome Measures
To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events
Response rate, Tumor shrinkage rate, Liver resection rate, R0 liver resection rate( pathologically confirmed ), Progression-free survival(CT/MRI image assessed by the attending physician), Time to treatment-failure, Overall survival, Incidence of adverse events (drag-related, surgery-related) , Exploratory endpoints
Progression-free survival among the RAS wild type subpopulation
Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01834014
Brief Title
Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases
Acronym
ATOM ES
Official Title
An Exploratory Study to Evaluate Biomarkers as Predictive and /or Prognostic Factors of Benefit From Randomized Phase ll Study of mFOLFOX6+Bevacizumab or mFOLFOX6+Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EPS Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.
Detailed Description
The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis, Colorectal Cancer
Keywords
Liver only metastasis from KRAS Exon 2 wild type, Liver only metastasis from RAS wild type
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mFOLFOX + Bmab
Arm Type
Experimental
Arm Description
mFOLFOX plus bevacizumab
Arm Title
mFOLFOX + Cmab
Arm Type
Active Comparator
Arm Description
mFOLFOX plus cetuximab
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Intervention Type
Drug
Intervention Name(s)
L-OHP
Other Intervention Name(s)
Oxaliplatin
Intervention Description
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Intervention Type
Drug
Intervention Name(s)
l-LV
Other Intervention Name(s)
Levofolinate
Intervention Description
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
Fluorouracil
Intervention Description
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
Fluorouracil
Intervention Description
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Primary Outcome Measure Information:
Title
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)
Description
To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed
Time Frame
Baseline, Cycle 8, Progression Disease
Secondary Outcome Measure Information:
Title
To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events
Description
Response rate, Tumor shrinkage rate, Liver resection rate, R0 liver resection rate( pathologically confirmed ), Progression-free survival(CT/MRI image assessed by the attending physician), Time to treatment-failure, Overall survival, Incidence of adverse events (drag-related, surgery-related) , Exploratory endpoints
Time Frame
Baseline, Cycle 8, Progression Disease
Title
Progression-free survival among the RAS wild type subpopulation
Time Frame
assessed every 8 weeks, up to 4 years
Title
Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma
Time Frame
Baseline, Cycle 8, Progression Disease
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ichinosuke Hyodo, MD, PhD
Organizational Affiliation
Graduate School of Comprehensive Human Sciences, Tsukuba University, Department of Gastroenterology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoshihiro Kakeji, MD, PhD, FACS
Organizational Affiliation
Kobe University Graduate School of Medicine, Division of Gastrointestinal Surgery, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
EPS Corporation
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-0814
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases
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