Randomized pahse III study evaluating the efficacy of hepatic arterial infusion chemotherapy for metastatic colorectal cancer patients with unresectable liver metastases

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2008
INTERVENTION: In the tested group, after the radiological placement of port and catheter system, hepatic arterial infusion using 5FU is performed within 6 months at the longest, and then FOLFOX+Bevacizumab therapy is performed. In the control group, FOLFOX+Bevacizumab therapy is performed. CONDITION: Colorectal cancer PRIMARY OUTCOME: Overall survival period SECONDARY OUTCOME: Adverse events; Time to treatment failure INCLUSION CRITERIA: 1)pathologically confirmed colorectal cancer 2)ALP more than 600 IU/L and unresectable liver metastases 3)No prior treatment using L‐OHP or Bevacizumab 4)20 years old or more 5)Performance status (ECOG):0‐2 6)No mtter of measurable lesion 7)Previous chemotherapy as folloes; ‐ No prior chemotherapy ‐ Chemotherapy of fluoropyrimidines for less than 2 weeks ‐ Previous adjuvant chemotherapy of fluoropyrimidines with more than 6 months interval to the recurrence, and no previous chemotherapy to the recurrence 8)Within normal function of major organs 9)More than 8 weeks survival expected 10)Written informed consent
Epistemonikos ID: bae100598340f59452fb0288676f4c01b8c477a2
First added on: Aug 21, 2024