Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM ES)

EPS Corporation

Status: Completed

Conditions: Liver Metastasis; Colorectal Cancer

Treatments: Drug: 5-FU; Drug: L-OHP; Drug: l-LV; Drug: Cetuximab; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01834014

UMIN000010429 (Other Identifier)

ATOM Exploratory study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

mFOLFOX + Bmab

Experimental group

Description:

mFOLFOX plus bevacizumab

Treatment:

Drug: Bevacizumab

Drug: l-LV

Drug: 5-FU

Drug: L-OHP

Drug: 5-FU

mFOLFOX + Cmab

Active Comparator group

Description:

mFOLFOX plus cetuximab

Treatment:

Drug: Cetuximab

Drug: l-LV

Drug: 5-FU

Drug: L-OHP

Drug: 5-FU