Trial | NCT03031444  Report issue

Title

Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis
A Multicenter Study of Prognosis and the Efficacy Comparison of Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Patients(Clinical Risk Score≥3) of Resectable Colorectal Liver Metastasis

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    135
This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.

The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.
Resection could prolong the survival of colorectal liver metastasis patients, however,the curative resection rate was still low and more than 2/3 of the patients would experience tumor recurrence.This study was designed to formulate a more accurate and individual evaluation system via the multivariate analysis.

Up to now, there was no data to demonstrate the addition of cetuximab to perioperative chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was also designed to elucidate this question and to observe the objective response rate(ORR) and the safety data of the regime.
Study Started
Jan 31
2016
Primary Completion
Dec 30
2020
Study Completion
Dec 30
2020
Last Update
Feb 01
2021

Drug Cetuximab plus FOLFIRI/FOLFOX

cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy

  • Other names: Erbitux, C225

Drug FOLFIRI/FOLFOX/CapeOX

to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)

  • Other names: XELOX

chemotherapy plus cetuximab Active Comparator

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]

perioperative chemotherapy alone Active Comparator

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.

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
No Results Posted