Resectable colorectal liver metastases
Conditions
Interventions
Surgical hepatectomy followed by chemotherapy (mFOLFOX6) 12cycles. mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biwee
Sponsors
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically proven colorectal cancer (2) Resectable synchronous and metachronous liver metastases (3) Metastatic colorectal cancer with EGFR expressed (4) KRAS wild type in codon 12, 13 (5) Age over 20 years (6) ECOG Performance Status(PS) 0-1 (7) Presence of measurable lesion in liver (RECIST Ver.1.1) (8) No prior chemotherapy for colorectal cancer (9) Patiens have enough organ function for study treatment (10) Life expectancy of more than 3 months (11) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Extrahepatic metastases or history of extrahepatic metastases (2) Metachronous 1 liver metastasis (3) More than 9 liver metastases (4) Prior local therapy for liver metastases (5) Severe comorbidity (6) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (7) Severe infectious disease (8) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding . Women with a positive pregnancy test (9) Psychological disorder (10) Considered not appropriate for surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Disease free survival, Safety, Postoperative complications, R0 rate, Liver resectability, Response rate | — |
Countries
Japan
Contacts
Public ContactKiyoshi Hasegawa, Masaru Oba
The University of Tokyo Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Outcome results
None listed