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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


N/A
20 Years
80 Years
Open (Enrolling)
Both
Liver Only Metastasis From Colorectal Cancer ( KRAS Wild-type )

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)

Outcome Description:

To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed

Outcome Time Frame:

Baseline, Cycle 8, Progression Disease

Safety Issue:

No

Principal Investigator

Ichinosuke Hyodo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Graduate School of Comprehensive Human Sciences, Tsukuba University, Department of Gastroenterology

Authority:

Japan: Ministry of Health, Labor and Welfare of Japan

Study ID:

ATOM Exploratory study

NCT ID:

NCT01834014

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Liver Only Metastasis From Colorectal Cancer ( KRAS Wild-type )
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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