Colorectal cancer
Conditions
Interventions
Period of intervension: 8 cycles of chemotherapy, mainly for 6 months.
Sponsors
Department of Gastroenterological Surgery, Tokai University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=20 yrs. 2. Pathologically proved colorectal cancer (CRC). 3. Liver-specific metastases. 4. Primary lesion resected or under controlled. 5. Metastatic target legions evaluable on imaging modalities, for example changes in sizes and numbers. 6. ECOG performance status 0 or 1. 7. Healthy primary organs satisfying all listed below: - WBC >=2,000 /uL and <=2,000 /uL - Neutrophil count >=1,500 /uL - Platelet count >=85,000 /uL - Hemoglobin >=8.0 g/dL - AST (GOT) <=150 IU/L and ALT (GPT) <=175 IU/L - Serum bilirubin >=2.0 mg/dL - Serum creatinine >=1.8 mg/dL - Normal electrocardiography - Written informed consent from the objects
Exclusion criteria
Exclusion criteria: 1. Intestinal pneumonia presenting clinical signs. 2. Severe infectious diseases. 3. Severely complicated diseases including heart failure, liver malfunction, renal failure and uncontrolled diabetes. 4. Anorexia 5. Women who are pregnant, lactate or have a probability of pregnancy. 6. History of allergy against fluorouracil, leucovorin, oxaliplatin and/or cetuximab. 7. Patients whom the researcher judged as ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year relative-free survival after liver surgery Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Response rate Progression-free survival in unresectable cases Intra- and extra-hepatic recurrence rate | — |
Countries
Japan
Contacts
Public ContactAkira Tanaka
Tokai University School of Medicine Department of Gastroenterological Surgery
Outcome results
None listed