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

Conditions

• Liver Only Metastasis From KRAS Exon 2 Wild Type (Under Protocol 1.0-1.2 Edition) and RAS Wild Type (Under Protocol 2.0 Edition) Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

20 Years - 80 Years

Healthy Volunteers

Not accepted

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study Details

The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.

Key Dates

First listed

Apr 22, 2013

Start date

May 31, 2013

Status verified

Aug 2017

Primary completion

Mar 31, 2017

Completion

Mar 31, 2017

Study Design

Enrollment

122 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: mFOLFOX + Bmab
  mFOLFOX plus bevacizumab
• Active Comparator: mFOLFOX + Cmab
  mFOLFOX plus cetuximab

Primary Outcome Measure

Progression-free survival [ Time Frame: assessed every 8 weeks, up to 4 years ]