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

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 - Exploratory study in achievement of improved survival by molecular targeted chemotherapy and liver resection for not optimally resectable colorectal liver metastases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010429

Enrollment

100

Registered

2013-04-05

Start date

2013-05-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer

Interventions

mFOLFOX6 + bevacizumab mFOLFOX6 + cetuximab

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS); centrally assessed	—

Secondary

Measure	Time frame
1) To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events - Response rate (RR) - Tumor shrinkage rate at week 8 - Liver resection rate - R0 liver resection rate (patholigically confirmed) - Progression-free survial (PFS); CT/MRI image assessed by the attending physician - Time to treatment-failure (TTF) - Overall survival (OS) - Incidence of adverse events (drag-related, surgery-related) - Exploratory endpoints - Primary endpoint and secondary endpoints in the RAS wild-type subpopulation 2) Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma	—

Measure

Time frame

1) To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events - Response rate (RR) - Tumor shrinkage rate at week 8 - Liver resection rate - R0 liver resection rate (patholigically confirmed) - Progression-free survial (PFS); CT/MRI image assessed by the attending physician - Time to treatment-failure (TTF) - Overall survival (OS) - Incidence of adverse events (drag-related, surgery-related) - Exploratory endpoints - Primary endpoint and secondary endpoints in the RAS wild-type subpopulation 2) Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma

—

Countries

Japan

Contacts

Public ContactEPS Corporation

EPS Corporation CRO Company Clinical Information Division

prj-atomdc@eps.co.jp03-5684-7767

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026