NCT02481661

Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 610 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).

Detailed description

Objective: To compare the outcomes(including 5 year relapse free survival rate, 5 year overall survival rate, retaining pulmonary function and the rates of loco-regional and systemic recurrence ) of patients with peripheral stage IA (≤ 2 cm) non-small cell lung cancer undergoing anatomic segmentectomy vs lobectomy. And to evaluate whether the anatomic segmentectomy is an optimal type of surgery for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS. * Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS. Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	segmentectomy	segmentectomy in Arm I and lobectomy in Arm II

Timeline

• Start date: 2015-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2015-06-25
• Last updated: 2015-06-25

Locations

1 site across 1 country: China