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

September 4, 2023 updated by: Haiquan Chen, Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

634

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Please Select
      • Shanghai, Please Select, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival
Time Frame: 5 years
The event is defined as the death due to any causes.
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SELLAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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