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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Penghao Deng
18301050196@fudan.edu.cn
+86-13278979834
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 684
Treatments
Experimental: Arm Selective lymph node dissection
Lower mediastinal lymph node clearance is not required for upper lobe tumors and upper mediastinal lymph node clearance is not required for lower lobe tumors in the group
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov