This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.
Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P \< 0.001) for non-small cell lung cancer ≤ 2 cm (CTR \> 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,120
Patients receive segmentectomy
Patients receive lobectomy
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITING5-year Disease-Free Survival
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Time frame: From date of the recruitment, assessed up to 60 months
30-day Morbidity and mortality rates
The rates of complications and death related to treatment during perioperative period
Time frame: From date of the recruitment, assessed up to 30 days
Pulmonary function in the first year after surgery
The Forced expiratory volume in one second (FEV1) in liter
Time frame: From date of the 3rd, 6th, and 12th month after surgery
3-year Disease-Free-Survival
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Time frame: From date of the recruitment, assessed up to 36 months
5-year overall Survival
The time interval from randomization to death caused by any reason
Time frame: From date of the recruitment, assessed up to 60 months
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