Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)

Phase 3

Recruiting

• Conditions: Lymph Node Metastasis; Lung Adenocarcinoma
• Interventions: Procedure: Selective Lymph Node Dissection

• Registration Number: NCT06031246
• Lead Sponsor: Fudan University

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment. The main questions it aims to answer are:

The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2026-01-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 634

Inclusion Criteria

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable peripheral cT1N0M0 tumors with CTR>0.5 located in the apical segment;
6. Non-lepidic predominant invasive NSCLC dignosed by frozen section;
7. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria

1. Not cT1N0M0;
2. Nodules not located in the apical segment or CTR≤0.5;
3. Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Selective Lymph Node Dissection	Selective Lymph Node Dissection	Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR\>0.5 Located in the Apical Segment

Primary Outcome Measures

Name	Time	Method
5-year overall survival	5 years	The event is defined as the death due to any causes.

Secondary Outcome Measures

Name	Time	Method
5-year recurrence-free survival	5 years	The event is defined as the tumor recurrence.
Lymph node metastasis	5 years	the lymph node metastasis situation of each pathological subtype
The accuracy of frozen section	5 years	The concordance of frozen section and final pathological diagnosis for invasiveness

Trial Locations

Locations (1)

Chaoqiang Deng; 🇨🇳 Shanghai, Please Select, China