Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis (PARECEC)
Colorectal Cancer Stage IV, Metastasis
About this trial
This is an interventional treatment trial for Colorectal Cancer Stage IV focused on measuring colorectal liver metastasis, preoperative, chemotherapy, targeted therapy
Eligibility Criteria
Inclusion Criteria:
- good performance status
- pathologic diagnosis of colorectal cancer
- Rat sarcoma viral oncogene homolog(RAS) wild-type
- radiologic confirmation the resectability of liver metastases
- enough future liver remnant
- Clinical Risk Score≥3
- treatment naive
- extra-hepatic metastases could be resected completely, if exist
Exclusion Criteria:
- poor performance status, could not tolerate chemotherapy or operation
- other malignancy history or synchronously
- extra-hepatic metastases could not be resected completely, if exist
- received other treatment previously
Sites / Locations
- Beijing Cancer Hospital
- West China Hospital, Sichuan University
- First Affiliated Hospital of Kunming Medical University
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
chemotherapy plus cetuximab
perioperative chemotherapy alone
Cetuximab plus FOLFIRI/FOLFOX:FOLFIRI plus cetuximab [Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1;Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1;5-fluoruracil(5-FU) 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion.Repeat every 2 weeks.Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks] or FOLFOX plus Cetuximab [Oxaliplatin 85 mg/m2 IV over 2 hours, day 1 Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks;Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks]
FOLFIRI/FOLFOX/CapeOX:routine perioperative chemotherapy including FOLFIRI[Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1 5-FU 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks] or FOLFOX[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1;Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks] or CapeOX[Oxaliplatin 130 mg/m2 IV over 2 hours, day 1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks] was adopted in this control arm.