Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in NSCLC (ECTOP-1010)

Recruiting

• Conditions: Non-small Cell Lung Cancer; Carcinoma

• Registration Number: NCT05094882
• Lead Sponsor: Fudan University

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1010. Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes (Group 11-13) in Non-small Cell Lung Cancer: a Multi-center, Prospective observational Clinical Trial

Detailed Description

Patients would be evaluated whether meet the criteria as clinical stage T1 non-small Cell Lung Cancer. Then, he/she would receive lobectomy. Finally, the detailed anatomical location of group 11-13 would be recorded immediately after surgery and their metastasis pattern would be explored in the follow-up period.

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-24
• Study First Posted: 2021-10-26
• Study Start: 2021-12-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Preoperative examination showed patients with clinical T1 peripheral non-small cell lung cancer (NSCLC);
2. The lesion is located in a single lung segment or between two adjacent lung segments;
3. Perform radical lobectomy;
4. The preoperative examination did not reveal unresectable lymph nodes;
5. Have not received any other tumor-related treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before surgery;
6. No malignant tumor history;
7. No contraindications to surgery (ECOG score 0-1 points);

Exclusion Criteria

1. Pathology revealed patients with non-T1 stage non-small cell lung cancer (NSCLC);
2. Radical lobectomy is not performed;
3. Acception of any anti-tumor treatment before surgery (excluding Chinese medicine treatment);
4. Refused to enter the group or asked to leave the group.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
metastasis rate of group 11-13 LN	one month after surgery	metastasis rate of intrapulmonary lymph nodes (group 11-13 LN) in non-small cell lung cancer

Secondary Outcome Measures

Name	Time	Method
detailed anatomical location	immediately after surgery	number of group 11-13 intrapulmonary lymph nodes in Non-small cell lung cancer and their detailed anatomical location

Trial Locations

Locations (1)

Fudan University Cancer Center; 🇨🇳 Shanghai, Shanghai, China