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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Adenocarcinoma Lymph Node Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Selective Lymph Node Dissection

Intervention Type PROCEDURE

For patients with NSCLC with CTR\>0.5 located in the apical segment, the inferior mediastinal lymph node was not need to dissected

Interventions

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Selective Lymph Node Dissection

For patients with NSCLC with CTR\>0.5 located in the apical segment, the inferior mediastinal lymph node was not need to dissected

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No