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NCT Number: NCT06031246

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

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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Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Neoplasms Lymph Node Metastasis Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chaoqiang Deng

Shanghai, Please Select, 200032, China

Location status: Recruiting

Location contact

Chaoqiang Deng

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selective Lymph Node Dissection

Procedure

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

Primary outcomes

  1. 5-year overall survival

    Time frame: 5 years

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

Secondary outcomes

  1. Lymph node metastasis

    Time frame: 5 years

    the lymph node metastasis situation of each pathological subtype

  2. 5-year recurrence-free survival

    Time frame: 5 years

    The event is defined as the tumor recurrence.

  3. The accuracy of frozen section

    Time frame: 5 years

    The concordance of frozen section and final pathological diagnosis for invasiveness

Study contacts

Contact information is provided by the study sponsor or research team.

Chaoqiang Deng, M.D.

CONTACT

[email protected]

+86-13122677592

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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