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

NCT01834014 | Completed DMC

• 2 other identifiers: ATOM Exploratory studyUMIN000010429
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastasis; Colorectal Cancer

Keywords

Liver only metastasis from KRAS Exon 2 wild type; Liver only metastasis from RAS wild type

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, Cycle 8, Progression Disease

Secondary Outcomes (3)

• To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events

  Baseline, Cycle 8, Progression Disease

• 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

Study Arms (2)

mFOLFOX + Bmab

EXPERIMENTAL

mFOLFOX plus bevacizumab

Drug: Bevacizumab; Drug: L-OHP; Drug: l-LV; Drug: 5-FU

mFOLFOX + Cmab

ACTIVE COMPARATOR

mFOLFOX plus cetuximab

Drug: Cetuximab; Drug: L-OHP; Drug: l-LV; Drug: 5-FU

Interventions

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.

Also known as: Avastin

mFOLFOX + Bmab

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.

Also known as: Erbitux

mFOLFOX + Cmab

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.

Also known as: Oxaliplatin

mFOLFOX + Bmab; mFOLFOX + Cmab

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.

Also known as: Levofolinate

mFOLFOX + Bmab; mFOLFOX + Cmab

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.

Also known as: Fluorouracil

mFOLFOX + Bmab; mFOLFOX + Cmab

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.

You may not qualify if:

• None

Sponsors & Collaborators

• EPS Corporation: lead

Study Sites (1)

EPS Corporation

Shinjuku-ku, Tokyo, 162-0814, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Cetuximab; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: April 17, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

JP (1)