Removing or Leaving Out One Lymph Node Group During Early Lung Cancer Surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early-stage (stage I) non-small cell lung cancer in the left lung, shown as a single solid nodule, who are planned for lung surgery. Half will have station 4L lymph nodes removed, half will not.

Age

18 to 75 years

Sex

Men and women

Disease stage

Stage I (T1-T2aN0M0) non-small cell lung cancer that can be removed by surgery. A single solid nodule in the left lung, 4 cm (1.6 in) or smaller. Invasive cancer confirmed by a quick pathology check during surgery.

Earlier treatment

No earlier radiotherapy or chemotherapy for this lung cancer. No earlier lung surgery.

Main reasons for not taking part

• Cancer that is not invasive
• Surgery other than segmentectomy or lobectomy
• Tumor not fully removed or tumor left behind
• Another cancer in the past
• Earlier lung surgery

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

This multicenter, prospective, randomized clinical trial will enroll adults aged 18 to 75 years with resectable clinical stage I (T1-T2aN0M0) invasive non-small cell lung cancer presenting as a single solid nodule (consolidation-to-tumor ratio 1.0) in the left lung. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer and completion of standard lung resection and systematic mediastinal lymph node dissection, participants will be randomly assigned 1:1 either to undergo station 4L lymph node dissection or to omit station 4L dissection. The primary hypothesis is that omitting station 4L dissection is noninferior to performing it with respect to 3-year disease-free survival. Secondary outcomes include 3-year overall survival, perioperative complications, 90-day mortality, and station 4L nodal metastasis.

The 2 groups in the trial

• Station 4L Lymph Node DissectionTreatment being tested

  Participants undergo complete lung resection and systematic mediastinal lymph node dissection, including surgical dissection of station 4L lymph nodes.

• No Station 4L Lymph Node DissectionNo study treatment, for comparison

  Participants undergo complete lung resection and systematic mediastinal lymph node dissection, but station 4L lymph nodes are not surgically removed.