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Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial.
Cancer Manag Res. 2020; 12:4633-4643.CM

Abstract

The efficacy and possible role of epidermal growth factor receptor tyrosine kinase inhibitors in treating early-stage non-small-cell lung cancer have yet to be established. Therefore, we aimed to explore the efficacy and safety of icotinib in completely resected EGFR-mutant stage II-IIIA lung adenocarcinoma patients who underwent standard chemotherapy. This is a randomised, double-blinded, placebo-controlled, multicentre, Phase III trial. A total of 124 patients aged 18-75 years who qualified the inclusion criteria were recruited. These patients were randomised (1:1) to receive either icotinib (125 mg 3 times per day) or placebo (the same dosage and frequency) for 36 months, followed by a further 36 months of observational window. The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life. Analyses will be conducted in a full analysis set and a per-protocol set as well. To our knowledge, the present study is the first randomised, double-blinded, placebo-controlled, multicenter trial designed to explore efficacy and safety of icotonib in this population. The results obtained in the near future may provide potential guidance in clinical practice. Trial Registration: This trial was registered on www.ClinicalTrail.gov as NCT02125240.

Authors+Show Affiliations

Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.Department of General Thoracic Surgery, China-Japan Friendship Hospital, Beijing, People's Republic of China.Department of Medical Oncology, Beijing Hospital, Beijing, People's Republic of China.Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People's Republic of China.Department of Oncology, The First Affiliated Hospital of Chinese PLA General Hospital, Beijing, People's Republic of China.Department of Oncology, Chinese PLA General Hospital, Beijing, People's Republic of China.Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.Department of Respiratory Medicine, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.Department of Respiratory Medicine, Peking Union Medical College Hospital, Affiliated to Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.Department of Thoracic Surgery, Peking University People's Hospital, Beijing, People's Republic of China.Department of Thoracic Surgery, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, People's Republic of China.Department of Radiotherapy and Chemotherapy, Tangshan People's Hospital, Tangshan, Hebei, People's Republic of China.Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing, People's Republic of China.Department of Thoracic Surgery, Peking University First Hospital, Beijing, People's Republic of China.Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32606956

Citation

Liu, Yu-Tao, et al. "Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients With EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial." Cancer Management and Research, vol. 12, 2020, pp. 4633-4643.
Liu YT, Hao XZ, Liu DR, et al. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020;12:4633-4643.
Liu, Y. T., Hao, X. Z., Liu, D. R., Cheng, G., Zhang, S. C., Xiao, W. H., Hu, Y., Liu, J. F., He, M., Ding, C. M., Zhang, L., Wang, J., Li, H., Dong, G. L., Zhi, X. Y., Li, J., & Shi, Y. K. (2020). Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Management and Research, 12, 4633-4643. https://doi.org/10.2147/CMAR.S240275
Liu YT, et al. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients With EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020;12:4633-4643. PubMed PMID: 32606956.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. AU - Liu,Yu-Tao, AU - Hao,Xue-Zhi, AU - Liu,De-Ruo, AU - Cheng,Gang, AU - Zhang,Shu-Cai, AU - Xiao,Wen-Hua, AU - Hu,Yi, AU - Liu,Jun-Feng, AU - He,Ming, AU - Ding,Cui-Min, AU - Zhang,Li, AU - Wang,Jun, AU - Li,Hui, AU - Dong,Gui-Lan, AU - Zhi,Xiu-Yi, AU - Li,Jian, AU - Shi,Yuan-Kai, Y1 - 2020/06/17/ PY - 2019/11/27/received PY - 2020/04/21/accepted PY - 2020/7/2/entrez PY - 2020/7/2/pubmed PY - 2020/7/2/medline KW - EGFR mutation KW - adjuvant chemotherapy KW - icotinib KW - lung adenocarcinoma KW - non-small-cell lung cancer SP - 4633 EP - 4643 JF - Cancer management and research JO - Cancer Manag Res VL - 12 N2 - The efficacy and possible role of epidermal growth factor receptor tyrosine kinase inhibitors in treating early-stage non-small-cell lung cancer have yet to be established. Therefore, we aimed to explore the efficacy and safety of icotinib in completely resected EGFR-mutant stage II-IIIA lung adenocarcinoma patients who underwent standard chemotherapy. This is a randomised, double-blinded, placebo-controlled, multicentre, Phase III trial. A total of 124 patients aged 18-75 years who qualified the inclusion criteria were recruited. These patients were randomised (1:1) to receive either icotinib (125 mg 3 times per day) or placebo (the same dosage and frequency) for 36 months, followed by a further 36 months of observational window. The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life. Analyses will be conducted in a full analysis set and a per-protocol set as well. To our knowledge, the present study is the first randomised, double-blinded, placebo-controlled, multicenter trial designed to explore efficacy and safety of icotonib in this population. The results obtained in the near future may provide potential guidance in clinical practice. Trial Registration: This trial was registered on www.ClinicalTrail.gov as NCT02125240. SN - 1179-1322 UR - https://www.unboundmedicine.com/medline/citation/32606956/Icotinib_as_Adjuvant_Treatment_for_Stage_II-IIIA_Lung_Adenocarcinoma_Patients_with_EGFR_Mutation_(ICWIP_Study):_Study_Protocol_for_a_Randomised_Controlled_Trial L2 - https://dx.doi.org/10.2147/CMAR.S240275 DB - PRIME DP - Unbound Medicine ER -
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