Lung Adenocarcinoma, Lymph Node Metastasis
Conditions
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.
Interventions
PROCEDURESelective 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
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 years | The event is defined as the death due to any causes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node metastasis | 5 years | the lymph node metastasis situation of each pathological subtype |
| 5-year recurrence-free survival | 5 years | The event is defined as the tumor recurrence. |
| The accuracy of frozen section | 5 years | The concordance of frozen section and final pathological diagnosis for invasiveness |
Countries
China
Contacts
Primary ContactChaoqiang Deng, M.D.
Outcome results
None listed