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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000010429 | Other Identifier | UMIN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFOX + Bmab | Experimental | mFOLFOX plus bevacizumab |
|
| mFOLFOX + Cmab | Active Comparator | mFOLFOX plus cetuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPS Corporation | Shinjuku-ku | Tokyo | 162-0814 | Japan |
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| 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. |
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| 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. |
|
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| 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. |
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| 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. |
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| 5-FU | Drug | 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. |
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| 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 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000068818 | Cetuximab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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