Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Selective lymph node dissection
Procedure/SurgeryFor 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)
Treatment groups
684 Participants
are divided into 1 treatment groupGroup A: Arm Selective lymph node dissectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year disease-free survival
Time frame
From enrollment to the end of treatment at 2 yearsSecondary outcomes
1
2-year overall survival
Time frame
From enrollment to the end of treatment at 2 yearsOther outcomes
1
5-year disease-free survival
Time frame
From enrollment to the end of treatment at 5 years2
5-year overall survival
Time frame
From enrollment to the end of treatment at 5 yearsSponsors and contacts
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Source ClinicalTrials.gov