title: Gefitinib Combined With Standard Chemoradiotherapy in EGFR-Mutant Locally Advanced Non-Small-Cell Lung Cancer: The LOGIK0902/OLCSG0905 Intergroup Study Protocol.
abstract: Herein, we describe an ongoing phase II trial in patients with locally advanced non-small-cell lung cancer (NSCLC) with mutated epidermal growth factor receptor (EGFR). Patients with chemotherapy-naive locally advanced disease with active EGFR mutations will receive the induction treatment, specified as gefitinib monotherapy (250 mg/body) for 8 weeks. Patients whose disease has not progressed during the induction therapy will receive cisplatin and docetaxel (40 mg/m(2)) on days 1, 8, 29, and 36, and concurrent 3-dimensional conformal thoracic radiotherapy with a single daily fraction of 2 Gy, for 5 consecutive days each week to provide a total dose of 60 Gy. The primary end point is overall survival at 24 months. A target sample size of 21 evaluable patients is considered sufficient to validate an expected rate of 85%, and 60% would be the lower limit of interest, with 80% power and a 1-sided α of 5%. Secondary end points include toxicity, response rate, and overall survival. This study will clarify whether tyrosine kinase inhibitors targeted to EGFR can produce a maximal effect in selected NSCLC patients with the relevant driver mutation, even in the locally advanced setting.
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan. Electronic address: khotta@okayama-u.ac.jp.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.affiliation: Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Jiichiro
authors.initials: J
authors.lastname: Sasaki
authors.affiliation: Department of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan.
authors.forename: Sho
authors.initials: S
authors.lastname: Saeki
authors.affiliation: Department of General Internal Medicine 4, Kawasaki Medical School, Okayama, Japan.
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.affiliation: Department of Radiology, Okayama University Hospital, Okayama, Japan.
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Katsui
authors.affiliation: Department of Respirology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Takayama
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Shikoku Cancer Center Hospital, Matsuyama, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.affiliation: Department of Radiation Oncology, Ion Beam Therapy Center, SAGA-HIMAT Foundation, Tosu, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Shioyama
authors.affiliation: Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Bessho
authors.affiliation: Department of Research and Development of Next Generation Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Kishimoto
authors.affiliation: Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.affiliation: Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichinose
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000235:genetics; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics / Q000473:pathology / Q000628:therapy; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D066246:ErbB Receptors / Q000235:genetics; D005500:Follow-Up Studies; D000077156:Gefitinib; D008175:Lung Neoplasms / Q000235:genetics / Q000473:pathology / Q000628:therapy; D009154:Mutation / Q000235:genetics; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D012107:Research Design
chemical_list: D014408:Biomarkers, Tumor; D002945:Cisplatin; D000077143:Docetaxel; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib; D011799:Quinazolines; D043823:Taxoids
keywords: Chemoradiation; Cure; EGFR mutation; Locally advanced setting; Lung cancer