Comparing Two Lung Surgeries for Small Lung Adenocarcinoma Tumors

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 a small lung adenocarcinoma (2 cm (0.8 in) or less) whose surgery sample shows no micropapillary or solid subtype. It compares removing part of a lung lobe (segmentectomy) with removing the whole lobe (lobectomy).

Age

20 to 79 years

Sex

Men and women can join.

Disease stage

Lung adenocarcinoma with tumor size <= 2cm (0.8 in) on CT. A single nodule in the outer lung, or a lesion that is MIA or less invasive. The nodule is not a pure glass nodule (consolidation to tumor ratio >= 0.25). During surgery, the frozen section confirms invasive adenocarcinoma with micropapillary and solid subtype negative (<= 5%) and tumor-free resection margins.

Earlier treatment

People cannot have had chemotherapy, radiation therapy or any other therapy before.

Biomarker or test result

Lung function must be good enough for both operations (FEV1 > 1.5L or FEV1% >= 60%). Performance status (ECOG) 0 to 2.

Main reasons for not taking part

• Pure ground glass nodule (consolidation to tumor ratio < 0.25)
• Nodule close to the lung hilus, so segmentectomy is not possible
• Micropapillary and solid subtype positive (> 5%), or adenocarcinoma in situ or minimally invasive adenocarcinoma on frozen section
• Lymph node spread or distant metastasis on imaging
• Other malignant tumors, severe heart, liver or kidney damage, or pregnant or breastfeeding women

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 20 and 79 years old?YesNo

What the trial wants to find out

This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.

The 2 groups in the trial

• SegmentectomyTreatment being tested

  Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed after a comprehensive evaluation. As with lobectomy, systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated in the same manner as with lobectomy. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy.

• LobectomyExisting treatment, for comparison

  lobectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intraoperatively. If the distance is either less than the maximum tumor diameter or ,20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.