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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 634
- Locations
- 1
- Primary Endpoint
- 5-year overall survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Selective Lymph Node Dissection (Procedure)
Outcomes
Primary Outcomes
5-year overall survival
Time Frame: 5 years
The event is defined as the death due to any causes.
Secondary Outcomes
- 5-year recurrence-free survival(5 years)
- Lymph node metastasis(5 years)
- The accuracy of frozen section(5 years)
Investigators
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University