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

August 1, 2017 updated by: EPS Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 162-0814
        • EPS Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mFOLFOX + Bmab
mFOLFOX plus bevacizumab
Drug: Bevacizumab
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.
Other Names:
  • Avastin
Drug: L-OHP
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.
Other Names:
  • Oxaliplatin
Drug: l-LV
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.
Other Names:
  • Levofolinate
Drug: 5-FU
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.
Other Names:
  • Fluorouracil
Drug: 5-FU
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.
Other Names:
  • Fluorouracil
Active Comparator: mFOLFOX + Cmab
mFOLFOX plus cetuximab
Drug: L-OHP
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.
Other Names:
  • Oxaliplatin
Drug: l-LV
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.
Other Names:
  • Levofolinate
Drug: 5-FU
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.
Other Names:
  • Fluorouracil
Drug: 5-FU
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.
Other Names:
  • Fluorouracil
Drug: Cetuximab
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.
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Cycle 8, Progression Disease

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Baseline, Cycle 8, Progression Disease
Progression-free survival among the RAS wild type subpopulation
Time Frame: assessed every 8 weeks, up to 4 years
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
Baseline, Cycle 8, Progression Disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EPS Corporation

Investigators

  • Principal Investigator: Ichinosuke Hyodo, MD, PhD, Graduate School of Comprehensive Human Sciences, Tsukuba University, Department of Gastroenterology
  • Principal Investigator: Yoshihiro Kakeji, MD, PhD, FACS, Kobe University Graduate School of Medicine, Division of Gastrointestinal Surgery, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 14, 2013

First Submitted That Met QC Criteria

April 14, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATOM Exploratory study
  • UMIN000010429 (Other Identifier: UMIN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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