Liver MetastasisATOM ESNCT01834014
Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases
A study testing Bevacizumab, Cetuximab and L-OHP in people with Liver Metastasis and Colorectal Cancer, run by EPS Corporation at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Liver Metastasis, Colorectal Cancer
- What is being tested?
- Bevacizumab, Cetuximab and L-OHP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteJapan
- Study dates
- May 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Liver Metastasis, Colorectal Cancer
- Being tested
- Bevacizumab, Cetuximab, L-OHP, l-LV, 5-FU
- Keywords
- Liver only metastasis from KRAS Exon 2 wild type, Liver only metastasis from RAS wild type
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
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.
CetuximabDrug
Also called Erbitux
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.
L-OHPDrug
Also called Oxaliplatin
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.
l-LVDrug
Also called Levofolinate
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.
5-FUDrug
Also called Fluorouracil
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.
5-FUDrug
Also called Fluorouracil
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.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX + Bmab | Experimental | mFOLFOX plus bevacizumab Receives: Drug: Bevacizumab; Drug: L-OHP; Drug: l-LV; Drug: 5-FU |
| mFOLFOX + Cmab | Active comparator | mFOLFOX plus cetuximab Receives: Drug: Cetuximab; Drug: L-OHP; Drug: l-LV; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Cycle 8, Progression Disease
Secondary outcomes (3)
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
Measured: Baseline, Cycle 8, Progression Disease
Progression-free survival among the RAS wild type subpopulation
Measured: assessed every 8 weeks, up to 4 years
Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma
Measured: Baseline, Cycle 8, Progression Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPS Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ichinosuke Hyodo, MD, PhD, Principal investigator, Graduate School of Comprehensive Human Sciences, Tsukuba University, Department of GastroenterologyYoshihiro Kakeji, MD, PhD, FACS, Principal investigator, Kobe University Graduate School of Medicine, Division of Gastrointestinal Surgery, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834014
- Sponsor's protocol ID
- ATOM Exploratory study
- Other IDs
- UMIN000010429
- Acronym
- ATOM ES
- Status last verified
- Aug 2017
- First submitted
- 14 Apr 2013
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01834014
- Acronym / sponsor ID
- ATOM ES / ATOM Exploratory study
- Conditions
- Liver Metastasis, Colorectal Cancer
- Keywords
- Liver only metastasis from KRAS Exon 2 wild type, Liver only metastasis from RAS wild type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- EPS CorporationUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX + Bmab | Experimental | Drug: Bevacizumab, Drug: L-OHP, Drug: l-LV, Drug: 5-FUmFOLFOX plus bevacizumab |
| mFOLFOX + Cmab | Active comparator | Drug: Cetuximab, Drug: L-OHP, Drug: l-LV, Drug: 5-FUmFOLFOX plus cetuximab |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin5 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. | Drug | mFOLFOX + Bmab |
| CetuximabAlso: Erbitux250 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. | Drug | mFOLFOX + Cmab |
| L-OHPAlso: Oxaliplatin85 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. | Drug | mFOLFOX + Bmab, mFOLFOX + Cmab |
| l-LVAlso: Levofolinate200 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. | Drug | mFOLFOX + Bmab, mFOLFOX + Cmab |
| 5-FUAlso: Fluorouracil400 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. | Drug | mFOLFOX + Bmab, mFOLFOX + Cmab |
| 5-FUAlso: Fluorouracil2400 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. | Drug | mFOLFOX + Bmab, mFOLFOX + Cmab |
Primary outcome
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)
Time frame: Baseline, Cycle 8, Progression Disease
To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed
3 secondary outcomes
To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events
Time frame: Baseline, Cycle 8, Progression Disease
Progression-free survival among the RAS wild type subpopulation
Time frame: assessed every 8 weeks, up to 4 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ichinosuke Hyodo, MD, PhD principal investigator
Graduate School of Comprehensive Human Sciences, Tsukuba University, Department of Gastroenterology
Yoshihiro Kakeji, MD, PhD, FACS principal investigator
Kobe University Graduate School of Medicine, Division of Gastrointestinal Surgery, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab, Cetuximab and L-OHP in people with Liver Metastasis and Colorectal Cancer, run by EPS Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS) (time frame: Baseline, Cycle 8, Progression Disease). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.