Selective lymph node removal for small non-small cell lung cancer

Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm: a Prospective， Single-arm, Multi-center, Phase Ⅱ Trial

This study is testing a new surgery method that aims to safely remove fewer lymph nodes in patients with small non-small cell lung cancer to see if it leads to better recovery and fewer complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 684 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06634979 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of a selective lymph node dissection strategy for patients with invasive non-small cell lung cancer (NSCLC) that have a central tumor ratio (CTR) between 0.5 and 1 and a diameter of 2 cm or less. The approach aims to minimize trauma by avoiding unnecessary lymph node removal based on tumor location and characteristics. The study builds on previous findings that certain tumor types and locations are less likely to metastasize, allowing for a more tailored surgical approach. By validating this selective strategy, the study seeks to improve patient outcomes while reducing surgical complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with surgically resectable cT1N0M0 invasive NSCLC and specific tumor characteristics.

Not a fit: Patients with lung cancer that does not meet the specific CTR and size criteria or those requiring complete surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to less invasive surgeries and improved recovery for patients with early-stage lung cancer.

How similar studies have performed: Previous studies have indicated the feasibility of selective lymph node dissection in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Volunteer to participate in a clinical study and be willing to follow and have the ability to complete all trial procedures;
* Age 18-80 years at time of signing informed consent (including threshold);
* ECOG score 0 or 1;
* No previous surgery for lung cancer;
* Intraoperative or postoperative pathologically confirmed non-small cell lung cancer;
* Single pulmonary nodule with mixed ground glass on CT, or multiple pulmonary nodules but the main lesion is the above nodules;
* The proportion of solid components of the nodule is between 0.5 and 1, and the total size of the nodule is less than or equal to 2 cm;
* Patients with clinical stage T1N0M0 surgically resectable;
* Primary treatment without radiotherapy or chemotherapy.

Exclusion Criteria:

* T1N0M0 with a clinical stage other than 0.5 \< CTR \< 1 and a diameter of ≤ 2 cm;
* Inability to perform complete surgical resection;
* cytology or histopathology confirms that it is a lung malignant tumor other than non-small cell lung cancer;
* Previous surgery for lung cancer;
* Patients who have received radiotherapy or chemotherapy for non-primary treatment.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Haiquan Chen — Fudan University
• Study coordinator: Penghao Deng

Conditions Lung Cancer; Lymph Node Dissection; Selective lymph node dissection