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

Not Applicable

Recruiting

• Conditions: Lung Neoplasms; Surgery
• Interventions: Procedure: Segmentectomy; Procedure: Lobectomy

• Registration Number: NCT04944563
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

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 Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-29
• Study Start: 2021-07-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-05
• Primary Completion: 2029-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1120

Inclusion Criteria

1. Patient aged 18-75 years old;
2. 6 mm ≤ tumor size ≤ 20 mm;
3. 0.25 < CTR < 1;
4. Center of tumor located in the middle third of the lung field;
5. ECOG score of 0,1 or 2;
6. Lung function (FEV1 ≥ 1 L and ≥ 70%);
7. Both lung segmentectomy and lobectomy could achieve R0 resection;
8. No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
9. No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
10. Single tumor nodule or the concomitant nodule < microinvasive tumor;
11. Written informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Segmentectomy	Segmentectomy	Patients receive segmentectomy
Lobectomy	Lobectomy	Patients receive lobectomy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China