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

Browse trials for

• Colorectal Neoplasms 5,599
• Neoplasm Metastasis 3,517
• Neoplasms, Second Primary 247

Keywords

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

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 110 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Lead sponsor

EPS Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Study arms

• Experimental
  mFOLFOX + Bmab

  mFOLFOX plus bevacizumab

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

• Active comparator
  mFOLFOX + Cmab

  mFOLFOX plus cetuximab

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

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.

  Also known as: Avastin

• 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.

  Also known as: Erbitux

• 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.

  Also known as: Oxaliplatin

• 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.

  Also known as: Levofolinate

• 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.

  Also known as: Fluorouracil

• Drug5-FU

  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.

  Also known as: Fluorouracil

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

   Time frame: Baseline, Cycle 8, Progression Disease

Secondary outcomes

1. 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

   Time frame: Baseline, Cycle 8, Progression Disease

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