Liver Metastasis, Colorectal Cancer
Conditions
Keywords
Liver only metastasis from KRAS Exon 2 wild type, Liver only metastasis from RAS wild type
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.
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.
Interventions
DRUGBevacizumab
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.
DRUGCetuximab
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.
DRUGL-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.
DRUGl-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.
DRUG5-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.
Sponsors
EPS Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS) | Baseline, Cycle 8, Progression Disease | To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events | 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 |
| 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 | — |
Countries
Japan
Outcome results
None listed