Treatment rationale and design of the induction chemotherapy and adjuvant thoracic radiation in resectable N2-3A/3B non-small cell lung cancer (ICAT) study

BACKGROUND: The optimal treatment strategy for stage N2–3A/3B non-small cell lung cancer (NSCLC) remains controversial owing to its heterogeneity. Although multimodal therapy is considered the standard therapeutic approach for stage N2–3A/3B resectable NSCLC patients, the optimal combination strategy still needs to be clarified. PATIENTS AND METHODS: In total, 25 male and female patients aged between 20 and 75 years with stage N2–3A/3B resectable NSCLC will be included. Eligible patients will undergo tri-modality therapy comprising induction chemotherapy (3 cycles of combination therapy with carboplatin and nab-paclitaxel), followed by surgery and postoperative radiotherapy. Recruitment was commenced in April 2017, with a planned last follow-up in March 2024. As of May 2019, 1 subject has been enrolled. The primary endpoint is the treatment completion rate. The secondary endpoints are objective response rate (ORR) of induction chemotherapy, treatment-related adverse event, recurrence-free survival (RFS) time, and overall survival (OS) time. RFS and OS time will be calculated as the time from this study registration to first recurrence and all-cause death, respectively. ETHICS AND DISSEMINATION: The protocol was approved by the institutional review boards of Kyoto Prefectural University of Medicine and all the participating hospitals. Written informed consent was obtained from all patients before registration, in accordance with the Declaration of Helsinki. The study results will be disseminated via publication in peer-reviewed journals. TRIAL REGISTRATION: Trial registration number UMIN000025010 and jRCT1051180028