This is a Phase II, multicenter,randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI as first-line treatment in patients with metastatic colorectal cancer (mCRC).
This is a Phase II, multicenter,randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI in not previously treated patients with metastatic colorectal cancer (mCRC). In experimental group, untreated patients with metastatic colorectal cancer will receive Irinotecan 150 mg/m2 (D1, q2w) , Xeloda 2000mg/m2 (D1-10, q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment. While in control group, patients with metastatic colorectal cancer will receive Irinotecan 180 mg/m2 (D1, q2w) , CF 300mg/m2 (D1 q2w), 5FU 400mg/m2, D1 2400 mg/m2, civgtt 44h (q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment.The primary endpoint is progression-free survival. Overall survival, Objective Response rate, adverse event and life quality will be assessed as secondary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
5 mg/kg intravenously administered on day 1 of a 2-week cycle.
2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.
180 mg/m2 intravenously administered on day 1 of a 2-week cycle.
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, China
Progression-free survival (PFS)
Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.
Time frame: 6 Months
Overall Response Rate (ORR)
Proportion of eligible patients with measurable lesions with a best overall response of CR or PR assessed by the attending physician.
Time frame: 6 Months
Overall survival (OS)
Time from the date of enrollment to death from any cause.
Time frame: 1 Year
Incidence of Adverse Events
The incidence of adverse events as graded by NCI-CTCAE v 4.0.
Time frame: 6 Months
Quality of life (QoL) Questionnaire
Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
Time frame: 6 Months
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400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.
300 mg/m2 intravenously administered on day 1 of a 2-week cycle.
150 mg/m2 intravenously administered on day 1 of a 2-week cycle.