EGFR positive and KRAS wild type colorectal cancer with liver metastases inappropriate for curative resection
Conditions
Interventions
Chemotherapy with modified FOLFOX6 plus cetuximab. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Liver resection (if possible,
Sponsors
Tohoku - Six Universities Research Group by Experts (T-SURGE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically proven colorectal cancer in EGFR positive and KRAS wild type (2) Measurable synchronous liver metastases or measurable metachronous liver metastases. - Synchronous liver metastasis: No prior treatment except for original resection. After original resection, curative resection past more than 6 weeks, non-curative resection past more than 4 weeks. - Metachronous liver metastasis: No prior treatment for liver metastases, more than 6 months after original postoperative adjuvant therapy (3) All metastases is unresectable with margin. Or residual liver less than 40% after resection. (4) Age >=20 (5) The Eastern Cooperative Oncology Group(ECOG) Performance Status(PS) 0-2 (6) Life expectancy of more than 3 months (7) With a written informed consent (8) Vital organ functions (listed below) are preserved within 2 weeks prior to entry i) Medullary function WBC >= 3,000/mm^3 Neurtophils >= 1,500/mm^3 Platelets >= 100,000/mm^3 ii) Liver function AST(GOT) <= ULN*5 ALT(GPT) <= ULN*5 Total bilirubin <= ULN*2 iii) Renal function Creatinine <= ULN*2
Exclusion criteria
Exclusion criteria: (1) Uncontrolled extrahepatic lesion (2) Symptomatic brain metastasis (3) Cardiac disease (over Grade 2 by CTCAE v4.0), or myocardial infarction within 1 year (4) Past or current history (within 5 years) of malignant disease, except for the early cancer healed clearly (5) Interstitial lung disease, or pulmonary fibrosis (6) Serious infectious disease (7) Serious complication (kidney failure, liver failure , hypertension, etc) (8) Peripheral neuropathy (over Grade 1 by CTCAE v4.0) (9) No willing of birth-control. Or pregnant or lactating women (10) Serious drug hypersensitivity or history of drug allergy of Fluorouracil, Levofolinate calcium and/or Oxaliplatin (11) Participation in other clinical trial within 4 weeks (12) History of serious drug hypersensitivity (13) Previously received on anti-EGFR antibody (14) Case whom investigator deny the enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate (Curative resection rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Resection rate of liver metastases, Tumor response rate, Adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Nitta
Iwate Medical University Dept. of Surgery
Outcome results
None listed