NIPH Clinical Trials Search

Research on biomarkers in "A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors"

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Colorectal cancer
Date of first enrollment	2015/07/15
Target sample size	300
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	FOLFOXIRI+/-Bevacizumab (To 12 courses) 5-FU+Levofolinate+/-Bevacizumab (From 13 courses) Bevacizumab 5mg/kg/bi-weekly Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly FOLFOXIRI+/-Cetuximab (To 12 courses) 5-FU+Levofolinate+/-Cetuximab (From 13 courses) Cetuximab (first time) 400 mg/m2/week Cetuximab (after 2nd time) 250 mg/m2/week Irinotecan 150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 2400mg/m2/bi-weekly

Outcome(s)

Primary Outcome	Correlation between the reported biomarkers or outcome and clinical response.
Secondary Outcome	Correlation between the new biomarkers or outcome and clinical response.

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	(1) Patients who are regarded as inadequate for study enrollment by investigators. (2) Patients who refuse to supply the section.