Colorectal cancer patients with unresectable liver metastasis
Conditions
Interventions
None listed
Sponsors
Surgery, Kyorin university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically proven colorectal cancers 2)Men and women aged 20 or over 3)Patients with evaluable lesions (RECIST criteria) Synchronous or metachronous liver metastasis (cases with metastasis outside the liver or regional lymph nodes are excluded) In a case of synchronous liver metastasis, any treatments except for resection of the primary tumor are not permitted, and at least 4weeks should have passed after resection of the primary tumor. In a case of metachronous liver metastasis, any treatments for liver metastasis are not permitted, and at least 6 months should have passed after adjuvant chemotherapy for the primary tumor. 4)Margin-free metastatectomy is assumed to be impossible. 5)The estimated residual liver volume after resection is assumed to be less than 40%. 6)The Eastern Cooperative Oncology Group(ECOG) Performance Status is 0 or 1. 7)Estimated survival time after treatment starts is assumed to be 3 months or more. 8)Informed consent should be complete, and written consent should be given by patients themselves 9)Within 2 weeks before treatment, laboratory data should meet the following criteria. If there are several test results during the due course, the most adjacent result should be adopted. No use of BTF and G-CSF within 2 weeks before the blood test is permitted. i)hematopoietic function WBC:>3000/mm3 neutrophi:>1500/mm3 Plt:>100000/mm3 Hb:>9.0g/dL ii)liver function AST(GOT):<ULNX2.5 AST(GPT):<ULNX2.5 T-Bil:<ULNX2 iii)renal function Cr:<ULNX2
Exclusion criteria
Exclusion criteria: 1) Patients with previous histories of severe drug hypersensitivity or drug allergies 2) Patients with multiple primaries 3) Patients with metastasis outside the liver and regional lymph nodes 4) Patients with infection (fever of 38 degrees C or over) 5) Patients with severe comobidities (interstitial pneumonia or pulmonary fibrosis, cardiac failure, renal failure, liver failure, uncontrollable diabetes or hypertension, jaundice) 6) Patients with pleural effusion or ascites requiring treatment 7) Patients with diarrhea (watery) 8) Patients receiving atazanavir sulfate or flucytosine treatment 9) Pregnant women and women suspected of being pregnant and lactating women 10) Patients evaluated as unsuitable for this trial by the doctor in charge 11) Patients with arterial or venous thrombosis in KRAS mutant cases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate in FOLFIRI+Cetuximab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate in FOLFOX+Bevacizumab treatment, response rate and efficacy in both treatments | — |
Countries
Japan
Contacts
Public ContactTakaaki Kobayashi
Kyorin university hospital surgery
Outcome results
None listed