Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm

NCT06634979 | Recruiting

• 1 other identifier: ECTOP-1027
• Study Type: interventional
• Target: 684
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigated the efficacy and safety of a selective lymph node strategy (no lower mediastinal lymph node dissection for upper lobe tumors and no upper mediastinal lymph node dissection for lower lobe tumors) in patients with 0.5 \< CTR \< 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 0.5 \< CTR \< 1 and ≤ 2 cm in diameter.

Conditions

Lung Cancer (NSCLC); Lymph Node Dissection

Keywords

Selective lymph node dissection

Outcome Measures

Primary Outcomes (1)

• 2-year disease-free survival

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (1)

• 2-year overall survival

  From enrollment to the end of treatment at 2 years

Other Outcomes (2)

• 5-year disease-free survival

  From enrollment to the end of treatment at 5 years

• 5-year overall survival

  From enrollment to the end of treatment at 5 years

Study Arms (1)

Arm Selective lymph node dissection

EXPERIMENTAL

Lower mediastinal lymph node clearance is not required for upper lobe tumors and upper mediastinal lymph node clearance is not required for lower lobe tumors in the group

Procedure: Selective lymph node dissection

Interventions

Selective lymph node dissection PROCEDURE

For 0.5 \< CTR \< 1 and ≤ 2 cm diameter cT1N0M0 invasive non-small cell lung cancer patient sex for selective lymph node (lower mediastinal lymph nodes are not required to be cleared for upper lobe tumors and upper mediastinal lymph nodes are not required to be cleared for lower lobe tumors)

Arm Selective lymph node dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Haiquan Chen

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Penghao Deng

CONTACT

+86-13278979834; 18301050196@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)