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

Not Applicable

Completed

• Conditions: Liver Metastasis; Colorectal Cancer
• Interventions: Drug: Bevacizumab; Drug: Cetuximab; Drug: L-OHP; Drug: l-LV; Drug: 5-FU

• Registration Number: NCT01834014
• Lead Sponsor: EPS Corporation

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.

Study Timeline

• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-14
• Study First Posted: 2013-04-17
• Study Start: 2013-05
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mFOLFOX + Bmab	l-LV	mFOLFOX plus bevacizumab
mFOLFOX + Cmab	l-LV	mFOLFOX plus cetuximab
mFOLFOX + Bmab	Bevacizumab	mFOLFOX plus bevacizumab
mFOLFOX + Bmab	L-OHP	mFOLFOX plus bevacizumab
mFOLFOX + Bmab	5-FU	mFOLFOX plus bevacizumab
mFOLFOX + Cmab	Cetuximab	mFOLFOX plus cetuximab
mFOLFOX + Cmab	L-OHP	mFOLFOX plus cetuximab
mFOLFOX + Cmab	5-FU	mFOLFOX plus cetuximab

Primary Outcome Measures

Name	Time	Method
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)	Baseline, Cycle 8, Progression Disease	To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed

Secondary Outcome Measures

Name	Time	Method
Progression-free survival among the RAS wild type subpopulation	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	Baseline, Cycle 8, Progression Disease
To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events	Baseline, Cycle 8, Progression Disease	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

Trial Locations

Locations (1)

EPS Corporation; 🇯🇵 Shinjuku-ku, Tokyo, Japan