Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04944563

Collaborator

(none)

1,120

Enrollment

Location

Arms

100.4

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Surgery	Procedure: Segmentectomy Procedure: Lobectomy	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

Actual Study Start Date :

Jul 20, 2021

Anticipated Primary Completion Date :

Dec 1, 2029

Anticipated Study Completion Date :

Dec 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Segmentectomy Patients receive segmentectomy	Procedure: Segmentectomy Patients receive segmentectomy
Active Comparator: Lobectomy Patients receive lobectomy	Procedure: Lobectomy Patients receive lobectomy

Arm

Intervention/Treatment

Experimental: Segmentectomy

Patients receive segmentectomy

Procedure: Segmentectomy

Patients receive segmentectomy

Active Comparator: Lobectomy

Patients receive lobectomy

Procedure: Lobectomy

Patients receive lobectomy

Outcome Measures

Primary Outcome Measures

5-year Disease-Free Survival [From date of the recruitment, assessed up to 60 months]
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality

Secondary Outcome Measures

30-day Morbidity and mortality rates [From date of the recruitment, assessed up to 30 days]
The rates of complications and death related to treatment during perioperative period
Pulmonary function in the first year after surgery [From date of the 3rd, 6th, and 12th month after surgery]
The Forced expiratory volume in one second (FEV1) in liter
3-year Disease-Free-Survival [From date of the recruitment, assessed up to 36 months]
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
5-year overall Survival [From date of the recruitment, assessed up to 60 months]
The time interval from randomization to death caused by any reason

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient aged 18-75 years old;
6 mm ≤ tumor size ≤ 20 mm;
0.25 < CTR < 1;
Center of tumor located in the middle third of the lung field;
ECOG score of 0,1 or 2;
Lung function (FEV1 ≥ 1 L and ≥ 70%);
Both lung segmentectomy and lobectomy could achieve R0 resection;
No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
Single tumor nodule or the concomitant nodule < microinvasive tumor;
Written informed consent.

Exclusion Criteria:

The tumor nodule is located in right middle lobe;
A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
A serious mental illness;
Pregnant and lactating women;
Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
With the history of cerebral infarction or cerebral hemorrhage within 6 months;
With the history of sustained systemic corticosteroid therapy within 1 month;
The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
Other unsuitable situations;