Prospective evaluation of watchful waiting for early-stage lung cancer with ground-glass opacity: a single-arm confirmatory multicenter study: Japan Clinical Oncology Group study JCOG1906 (EVERGREEN study)
Tomohiro Miyoshi, Keiju Aokage, Masashi Wakabayashi, Ryo Shimoyama, Tomoko Kataoka, Haruhiko Fukuda, Shun‐ichi Watanabe
Abstract
Among early-stage lung cancers that show ground-glass nodules on chest computed tomography, the lung cancer surgical study group of the Japan Clinical Oncology Group previously reported that nodules of ≤2 cm with a consolidation/tumor ratio of ≤0.25 were considered radiologically non-invasive cancers with a low risk of metastasis. However, there is no consensus based on high-quality evidence about the optimal timing of surgical intervention for radiologically non-invasive cancers. In June 2020, we launched a multi-institutional, single-arm confirmatory trial to evaluate the efficacy and safety of watchful waiting for patients with radiologically non-invasive lung cancer. It is planned that a total of 720 patients will be enrolled from 49 institutes over a 5-year period. The primary endpoint is 10-year overall survival (OS). The secondary endpoints are 5-year OS, operation-free survival, proportion of extensive lung resection, proportion of unresectable progression, lung cancer-specific survival and adverse events.