Comparing segmentectomy and lobectomy for small lung tumors

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

This study is testing whether a lung surgery called segmentectomy is just as good as a larger surgery called lobectomy for people with small lung tumors to see how it affects their chances of staying cancer-free and living longer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT04944563 on ClinicalTrials.gov

What this trial studies

This study investigates the long-term oncological effects of segmentectomy compared to lobectomy in patients with early-stage non-small cell lung cancer that is 2 cm or smaller and located in the middle third of the lung field. It aims to determine if segmentectomy is non-inferior in terms of disease-free survival and overall survival. The trial will randomly assign participants to receive either segmentectomy or lobectomy, with careful monitoring of outcomes. The research builds on previous findings regarding segmentectomy's effectiveness in the outer third of the lung field.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a single tumor nodule in the middle third of the lung field measuring between 6 mm and 20 mm.

Not a fit: Patients with tumors located in the right middle lobe or those with serious cardiopulmonary complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive surgical option for patients with small lung tumors while maintaining similar survival rates.

How similar studies have performed: Previous studies have shown success with segmentectomy in the outer third of the lung field, but this specific approach in the middle third is novel and untested.

Eligibility criteria

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;

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Liang Chen, M.D. — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Zhihua Li, M.D.

Conditions: Lung Neoplasms, Surgery, Non-small cell lung cancer, Segmentectomy, Lobectomy, the middle third of the lung field