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

Recruiting

• Conditions: Non-small Cell Lung Cancer; Carcinoma
• Interventions: Procedure: pulmonary lobectomy

• 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);

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RML	pulmonary lobectomy	patients who recieved the resection of right middle lobe ()
LUL	pulmonary lobectomy	patients who recieved the resection of left upper lobe (LUL)
LLL	pulmonary lobectomy	patients who recieved the resection of left lower lobe (LLL)
RUL	pulmonary lobectomy	patients who recieved the resection of right upper lobe (RUL)
RLL	pulmonary lobectomy	patients who recieved the resection of right lower lobe (RML)

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