1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer. 2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months. This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
180 mg/m2 IV every 2 weeks
400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe progression free-survival
defined as the time from enrollment to progression or death RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy
Time frame: 8 Months after the last subject participate in
Overall survival
defined as the time from enrollment to death
Time frame: 18 Months after the last subject participate in
Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability
Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0).
Time frame: 3 Months after the last subject end the treatment
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