Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selective Lymph Node Dissection.
- Who it may be relevant to
- Registry conditions: Lung Adenocarcinoma, Lymph Node Metastasis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- 5-year overall survival [Time frame: 5 years]
Secondary outcome measures (3)
- Lymph node metastasis [Time frame: 5 years]
- 5-year recurrence-free survival [Time frame: 5 years]
- The accuracy of frozen section [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chaoqiang Deng — Shanghai
Publications
- Zhang Y, Deng C, Luo X, Yu Y, Zhang Y, Chen H. Protocol of a single-arm, multicenter, phase III trial for selective lymph node dissection in cT1N0M0 invasive non-small cell lung cancer with consolidation-tumor ratio >0.5 located in the apical segment: Eastern Cooperative Thoracic Oncology Projects ECTOP-1018 (SELLAS study). J Thorac Dis. 2024 Nov 30;16(11):8142-8148. doi: 10.21037/jtd-24-1114. Epu PMID 39678839
Identifiers
NCT: NCT06031246 · SELLAS