title: Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The appropriateness of lobectomy for all elderly patients is controversial. Meanwhile, sublobar resection is associated with reduced operative risk, better preservation of pulmonary function, and a better quality of life, constituting a potential alternative to standard lobectomy for elderly patients with early-stage non-small cell lung cancer (NSCLC). To date, no randomized trial comparing sublobar resection and lobectomy focusing on elderly patients has been reported. We hypothesized that for patients at least 70 years old with clinical stage T1N0M0 NSCLC, sublobar resection is non-inferior to lobectomy for 3-year disease-free survival (DFS).
  
  
  METHODS
  This is a prospective, randomized, controlled multicenter non-inferiority trial with two study arms: sublobar resection and lobectomy groups. Comprehensive geriatric assessments will be acquired for each patient. A total of 339 subjects will be enrolled on the basis of power calculations, and participants followed up every 6 months post-operation for 3 years. In case of relapse, survival follow-up will be continued until 5 years or death. Pulmonary function testing will be performed at 6, 12, and 36 months post-operation. The primary outcome is 3-year DFS; secondary endpoints include peri-operative complications and mortality, hospitalization time, post-operative ventilator time, overall survival, 3-year recurrence rates, post-operative pulmonary function, quality of life, geriatric assessment data, and 4-year mortality index.
  
  
  CONCLUSIONS
  The present study is the only prospective, multicenter, randomized controlled trial comparing sublobar resection and lobectomy for elderly patients. The therapeutic outcomes of sublobar resection will be evaluated in comparison with lobectomy for elderly patients (≥70 years) with early-stage NSCLC.
  
  
  BACKGROUND
  NCT02360761 : 01/24/2015 (ClinicalTrials.gov).
authors.affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University, #11 Xizhimen South Avenue, Beijing, 100044, China.
authors.forename: Fan
authors.initials: F
authors.lastname: Yang
authors.affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University, #11 Xizhimen South Avenue, Beijing, 100044, China. eastlifer@sina.com.
authors.forename: Xizhao
authors.initials: X
authors.lastname: Sui
authors.affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University, #11 Xizhimen South Avenue, Beijing, 100044, China.
authors.forename: Xiuyuan
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University, #11 Xizhimen South Avenue, Beijing, 100044, China.
authors.forename: Lixue
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University, #11 Xizhimen South Avenue, Beijing, 100044, China.
authors.forename: Xun
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University, #11 Xizhimen South Avenue, Beijing, 100044, China.
authors.forename: Shaodong
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University, #11 Xizhimen South Avenue, Beijing, 100044, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Wang
mesh_terms: D000367:Age Factors; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D002681:China; D002985:Clinical Protocols; D018572:Disease-Free Survival; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D009367:Neoplasm Staging; D011013:Pneumonectomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: Elderly; Geriatric assessment; Lobectomy; Lung cancer; Pulmonary function; Sublobar resection; Survival