The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these trials is under-represented, as in most of the ongoing clinical trials. This study focuses on the elderly population of early stage lung cancer, and aims to investigate the outcome of lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC) in elderly patients.
This randomized trial is to the best of our knowledge the first one designed to compare sublobar resection and lobectomy for elderly patients, in order to address these open questions:In patients aged 70 years or older and with clinical stage T1N0M0 NSCLC, (1) whether sublobar resection can achieve similar disease-free survival compared to lobectomy, (2) whether sublobar resection can reduce the postoperative mortality and morbidity,(3) whether sublobar resection can reserve better pulmonary function and quality of life for elderly patients of NSCLC?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
339
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Beijing Haidian Hospital
Beijing, China
RECRUITINGPeking university people's hospital
Beijing, China
RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, China
RECRUITINGSir Run Run Shaw Hospital
Hangzhao, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
RECRUITINGTime To Disease free survival Event
The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason.
Time frame: 3 years
Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.
Perioperative complication is defined as the complication occurred after surgery and before discharge, or within 30 days postoperatively. Death cases during this period should be recorded as perioperative death.
Time frame: 1 months
Hospitalization time after surgery in Participants
Defined as the time interval from the day of operation to discharge.
Time frame: 1 months
Intubation time after surgery in Participants
Defined as the time interval from the day of operation to extubation.
Time frame: 1 months
Time To Overall survival Event
The time interval from randomization to death from any cause.
Time frame: 3 years
Percentage of Participants With Local Recurrence and Metastasis Event
The ratio of local recurrence and metastasis in 3 years from the day of randomization
Time frame: 3 years
Postoperative pulmonary function
The Forced expiratory volume in one second and the forced vital capacity at 6-, 12- and 36-month post of the day of randomization.
Time frame: 3 years
Percentage of Participants With VATS procedure
The ratio of video assisted thoracoscopic surgery in each group.
Time frame: 1 month
Scores on the quality of life questionaires
The scores of the 6-, 12- and 36-month questionaire on quality of life post of the day of randomization.
Time frame: 3 years
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