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Brief Title: Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
Official Title: Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
Study ID: NCT02125240
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Chaoyang Hospital, Beijing, Beijing, China
Beijing Hospital, Beijing, Beijing, China
Beijing Union Medical College Hospital, Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Science, Beijing, Beijing, China
China-japan friendship hospital in Beijing, Beijing, Beijing, China
Peking University First Hospital, Beijing, Beijing, China
Peking University People's Hospital, Beijing, Beijing, China
304 Hospital of PLA, Beijing, Beijing, China
Xuanwu Hospital, Capital Medical University, Beijing, Beijing, China
People's Liberation Army General Hospital (301 Hospital), Beijing, Beijing, China
Capital Medical University, Beijing Chest Hospital, Beijing, Beijing, China
Name: Yuan-Kai Shi, MD
Affiliation: Cancer Hospital, Chinese Academy of Medical Science
Role: PRINCIPAL_INVESTIGATOR