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

Lung Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031246
• Other study ID #: SELLAS
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: September 2023
• Source: Fudan University
• Contact: Chaoqiang Deng, M.D.
• Phone: +86-13122677592
• Email: fdudengcq[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 634
• Est. completion date: December 31, 2030
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Lymph Node Metastasis
• Lymphatic Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Chaoqiang Deng	Shanghai	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year overall survival	The event is defined as the death due to any causes.	5 years
Secondary	Lymph node metastasis	the lymph node metastasis situation of each pathological subtype	5 years
Secondary	5-year recurrence-free survival	The event is defined as the tumor recurrence.	5 years
Secondary	The accuracy of frozen section	The concordance of frozen section and final pathological diagnosis for invasiveness	5 years