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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Lymph Node Metastasis; Lung Adenocarcinoma

Treatments: Procedure: Selective Lymph Node Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06031246

SELLAS

Details and patient eligibility

About

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.

Enrollment: 634 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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634 participants in 1 patient group

Selective Lymph Node Dissection

Experimental group

Description:

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

Treatment:

Procedure: Selective Lymph Node Dissection