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

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06031246

Collaborator

(none)

634

Enrollment

Location

Arm

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Adenocarcinoma Lymph Node Metastasis	Procedure: Selective Lymph Node Dissection	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

634 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Procedure: 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

Arm

Intervention/Treatment

Experimental: 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

Procedure: 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

Outcome Measures

Primary Outcome Measures

5-year overall survival [5 years]
The event is defined as the death due to any causes.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
Resectable peripheral cT1N0M0 tumors with CTR>0.5 located in the apical segment;
Non-lepidic predominant invasive NSCLC dignosed by frozen section;
Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

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;
Receiving radiotherapy or chemotherapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chaoqiang Deng	Shanghai	Please Select	China	200032

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator: Haiquan Chen, M.D., Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haiquan Chen, Director in the Department of Thoracic Surgery, FUSCC, Fudan University

ClinicalTrials.gov Identifier:

NCT06031246

Other Study ID Numbers:

SELLAS

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma of Lung

Lymphatic Metastasis

Study Results

No Results Posted as of Sep 11, 2023