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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01834014
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Metastasis Colorectal Cancer Drug: Bevacizumab Drug: Cetuximab Drug: L-OHP Drug: l-LV Drug: 5-FU Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Fluorouracil

Active Comparator: mFOLFOX + Cmab
mFOLFOX plus cetuximab
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 Name: Erbitux

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 Name: 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 Name: 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 Name: 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 Name: Fluorouracil




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Progression-free survival among the RAS wild type subpopulation [ Time Frame: assessed every 8 weeks, up to 4 years ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834014


Locations
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Japan
EPS Corporation
Shinjuku-ku, Tokyo, Japan, 162-0814
Sponsors and Collaborators
EPS Corporation
Investigators
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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

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Responsible Party: EPS Corporation
ClinicalTrials.gov Identifier: NCT01834014    
Other Study ID Numbers: ATOM Exploratory study
UMIN000010429 ( Other Identifier: UMIN )
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Keywords provided by EPS Corporation:
Liver only metastasis from KRAS Exon 2 wild type
Liver only metastasis from RAS wild type
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Bevacizumab
Cetuximab
Fluorouracil
Liver Extracts
Hematinics
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic