Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm
Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm: a Prospective， Single-arm, Multi-center, Phase Ⅱ Trial
Fudan University
684 participants
May 1, 2024
INTERVENTIONAL
Conditions
Summary
The study investigated the efficacy and safety of a selective lymph node strategy (no lower mediastinal lymph node dissection for upper lobe tumors and no upper mediastinal lymph node dissection for lower lobe tumors) in patients with 0.5 \< CTR \< 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 0.5 \< CTR \< 1 and ≤ 2 cm in diameter.
Eligibility
Inclusion Criteria9
- Volunteer to participate in a clinical study and be willing to follow and have the ability to complete all trial procedures;
- Age 18-80 years at time of signing informed consent (including threshold);
- ECOG score 0 or 1;
- No previous surgery for lung cancer;
- Intraoperative or postoperative pathologically confirmed non-small cell lung cancer;
- Single pulmonary nodule with mixed ground glass on CT, or multiple pulmonary nodules but the main lesion is the above nodules;
- The proportion of solid components of the nodule is between 0.5 and 1, and the total size of the nodule is less than or equal to 2 cm;
- Patients with clinical stage T1N0M0 surgically resectable;
- Primary treatment without radiotherapy or chemotherapy.
Exclusion Criteria5
- T1N0M0 with a clinical stage other than 0.5 \< CTR \< 1 and a diameter of ≤ 2 cm;
- Inability to perform complete surgical resection;
- cytology or histopathology confirms that it is a lung malignant tumor other than non-small cell lung cancer;
- Previous surgery for lung cancer;
- Patients who have received radiotherapy or chemotherapy for non-primary treatment.
Interventions
For 0.5 \< CTR \< 1 and ≤ 2 cm diameter cT1N0M0 invasive non-small cell lung cancer patient sex for selective lymph node (lower mediastinal lymph nodes are not required to be cleared for upper lobe tumors and upper mediastinal lymph nodes are not required to be cleared for lower lobe tumors)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06634979