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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in Non-small Cell Lung Cancer: a Multi-center, Prospective Observational Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094882
• Other study ID #: ALMPILN
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: hong hu
• Phone: 86-13512102066
• Email: huhong0997[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non-small Cell Lung Cancer

Intervention

Procedure:
• pulmonary lobectomy
resection of lung lobe

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metastasis rate of group 11-13 LN	metastasis rate of intrapulmonary lymph nodes (group 11-13 LN) in non-small cell lung cancer	one month after surgery
Secondary	detailed anatomical location	number of group 11-13 intrapulmonary lymph nodes in Non-small cell lung cancer and their detailed anatomical location	immediately after surgery