A Phase 3 interventional study of VATS and Thoracotomy in Non-small Cell Lung Cancer, sponsored by Peking University People's Hospital. Status unknown at 6 sites in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Peking University People's Hospital · Phase 3, Interventional, and Treatment
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?
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 339 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Preoperative criteria (contrast-enhanced Computed tomography scan)
Intraoperative criteria
General criteria
Exclusion Criteria:
Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS).
Procedure: VATS · Procedure: Thoracotomy
Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.
Procedure: VATS · Procedure: Thoracotomy
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Also known as: Thoracoscopy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Also known as: Open surgery
Time 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
The scores of CGA and 4-year mortality index as a measure of predictive factor for the outcome of the elderly.
The scores of prospective CGA and 4-yr mortality index to predict the outcome of the elderly.
Time frame: 3 years
The total cost as a measure of the cost/benefit analysis
The cost/benefit analysis of sublobar resection versus lobectomy
Time frame: 3 years
The rate of pathologically noninvasive lung cancer with the radiologic character of C/T>0.5
The radiologic character of C/T\>0.5 has been considered as a pathologically noninvasive lung cancer. and the rate of pathologically noninvasive lung cancer will be used as a measure for the relation between the radiologic / pathologic character of primary non-small-cell lung cancer and prognosis.
Time frame: 1 month
The morbidity rate as a measure between the two different interventions as a Measure of Safety and Tolerability.
The morbidity rate after surgery for participants who underwent video-assisted thoracoscopic or open procedures a Measure of Safety and Tolerability.
Time frame: 3 years
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital