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Completed

NCT Number: NCT01834014

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

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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Key information

Conditions

Liver Metastasis Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EPS Corporation

Shinjuku-ku, Tokyo, 162-0814, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Cetuximab

Drug

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

L-OHP

Drug

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

l-LV

Drug

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

5-FU

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

EPS Corporation

Other

Registry information

Official study 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

Acronym: ATOM ES

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2013
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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