NCT02360761

Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy

Surgical Treatment of Elderly Patients With Early Stage Non-small Cell Lung Cancer (STEPS): Comparison Between Sublobar Resection and Lobectomy - an Open, Multicenter, Randomized Phase III Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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?

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	VATS	Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
PROCEDURE	Thoracotomy	Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2015-02-11
• Last updated: 2016-09-20

Locations

6 sites across 1 country: China