A randomized phase III trial of postoperative surveillance for pathological stage II and IIIA non-small cell lung cancer (JCOG2012, PHOENIX).
Kenta TaneSatoshi ShionoMasashi WakabayashiTomoko KataokaNoriko MitomeHaruhiko FukudaKeiju AokageShun-Ichi Watanabenull nullPublished in: Japanese journal of clinical oncology (2024)
The goal of postoperative surveillance following non-small cell lung cancer surgery is to detect recurrence and second primary malignancies while curative treatment is still possible. Although several guidelines recommend that patients have computed tomography (CT) scans every 6 months for the first 2 years after resection, then once a year, there is no evidence that it is effective for survival, especially in locally advanced non-small cell lung cancer. In October 2022, we launched a multi-institutional, randomized controlled phase III trial for pathological stage II and IIIA non-small cell lung cancer patients to confirm the non-inferiority of less intensive surveillance with less frequent CT scans versus standard surveillance in terms of overall survival. The primary endpoint is overall survival. We intend to enroll 1100 patients from 45 institutions over 4 years. The trial has been registered in the Japan Registry of Clinical Trials under the code jRCT1030220361 (https://jrct.niph.go.jp/latest-detail/jRCT1030220361).
Keyphrases
- phase iii
- clinical trial
- open label
- computed tomography
- phase ii
- double blind
- placebo controlled
- end stage renal disease
- public health
- advanced non small cell lung cancer
- dual energy
- ejection fraction
- chronic kidney disease
- newly diagnosed
- prognostic factors
- positron emission tomography
- study protocol
- image quality
- magnetic resonance imaging
- coronary artery disease
- single cell
- coronary artery bypass
- combination therapy