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

ConditionsLung AdenocarcinomaLymph Node Metastasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who sign the informed consent form and are willing to complete the study according to the plan;

Aged from 18 to 80 years old;

ECOG equals 0 or 1;

Not receiving lung cancer surgery before;

Disqualifiers

Not cT1N0M0;

Nodules not located in the apical segment or CTR≤0.5;

Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically;

Receiving lung cancer surgery before;

Trial design

Design model

Single group

Treatments tested in this trial

  • Selective Lymph Node Dissection

    Procedure/Surgery

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

Treatment groups

634 Participants
are divided into 1 treatment group
Group A: Selective Lymph Node DissectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

5-year overall survival

The event is defined as the death due to any causes.

Time frame
5 years

Secondary outcomes

1

Lymph node metastasis

the lymph node metastasis situation of each pathological subtype

Time frame
5 years
2

5-year recurrence-free survival

The event is defined as the tumor recurrence.

Time frame
5 years
3

The accuracy of frozen section

The concordance of frozen section and final pathological diagnosis for invasiveness

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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