Mediastinal lymph node dissection versus spared mediastinal lymph node dissection in stage IA non-small cell lung cancer presented as ground glass nodules: study protocol of a phase III, randomised, multicentre trial (MELDSIG) in China
Chenguang Li,
Tao Jiang,
Hongxu Liu,
Chenlei Zhang,
Changhao Liu,
Zuoqing Song,
Zhenfa Zhang,
Yunfeng Ni,
Renwang Liu
Affiliations
Chenguang Li
1 Department of Lung Cancer, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin`s Clinical Research Center for Cancer, Tianjin, China
Tao Jiang
Department of Molecular Neuropathology, Beijing Neurosurgical Institute, Capital Medical University, Beijing, China
Hongxu Liu
3 Department of Thoracic Surgery, Liaoning Cancer Institute and Hospital, Shenyang, Liaoning, China
Chenlei Zhang
3 Department of Thoracic Surgery, Liaoning Cancer Institute and Hospital, Shenyang, Liaoning, China
Changhao Liu
3 Department of Thoracic Surgery, Liaoning Cancer Institute and Hospital, Shenyang, Liaoning, China
Zuoqing Song
4 Department of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, China
Zhenfa Zhang
1 Department of Lung Cancer, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin`s Clinical Research Center for Cancer, Tianjin, China
Yunfeng Ni
2 Department of Thoracic Surgery, Air Force Medical University Tangdu Hospital, Xi`an, Shanxi, China
Renwang Liu
4 Department of Lung Cancer Surgery, Tianjin Medical University General Hospital, Tianjin, China
Introduction Radical surgery including mediastinal lymph node dissection is the standard treatment for early-stage non-small cell lung cancer (NSCLC). About 50% lung nodules are pure ground glass or part-solid nodules, which are predominantly clinical stage IA NSCLC. Non-solid nodules rarely develop mediastinal lymph node metastasis.Method and analysis A phase III study was started in China to evaluate the non-inferiority in overall survival of spared mediastinal lymph node dissection compared with mediastinal lymph node dissection in stage IA NSCLC. A total of 1362 patients will be enrolled from 4 institutions in 2–3 years. The second endpoints are relapse-free survival and perioperative data, including duration of hospitalisation, duration of chest tube placement, operation time, blood loss.Ethics and dissemination This protocol has been reviewed and approved by the Clinical Research Review Board of Tianjin Medical University Cancer Institute and Hospital. The findings will be disseminated in peer-reviewed publications.Trial registration number NCT04631770.
