The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.
This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma. Primary Outcome Measure: Disease-free survival between Icotinib group and placebo group. Secondary Outcome Measures: Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Hospital
Beijing, Beijing Municipality, China
Disease-free survival
DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.
Time frame: 36 months
Overall survival
OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Time frame: 60 months
Lung cancer symptoms and health-related quality of life (HRQoL) differences
Time frame: 60 months
Number of participants with adverse events
Time frame: 36 months
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