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Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

ConditionLung Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-79
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 20-79 years old, both male or female;

Tumor size <= 2cm on preoperative CT scan;

Peripheral solitary nodule or the associated lesion is MIA or less invasive lesion;

Preoperative CT indicated that the nodules were non-pure glass nodules (consolidation to tumor ratio >= 0.25);

Disqualifiers

Radiological pure ground glass nodules (consolidation to tumor ratio < 0.25);

The nodule is close to the lung hilus and is unable to perform segmentectomy;

Intraoperative frozen section confirmed with micropapillary and solid subtype positive (> 5%);

Intraoperative frozen section confirmed adenocarcinoma in situ and minimally invasive adenocarcinoma;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Segmentectomy

    Procedure/Surgery

    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. 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 intra-operatively. 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.

  • Lobectomy

    Procedure/Surgery

    Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy 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 intra-operatively. 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.

Treatment groups

690 Participants
are divided into 2 treatment groups
Group A: SegmentectomyExperimental treatment 1 intervention
Group B: LobectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

recurrence-free survival rate

Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause

Time frame
5 year

Secondary outcomes

1

overall survival

Overall survival (OS) was defined as the time from surgery until death from any cause

Time frame
5 year
2

Post-operative respiratory function

The post-operative respiratory function will be evaluated by FEV1% and FVC.

Time frame
6 months
3

Operation time

The surgery time in both groups.

Time frame
24 hours
4

Blood loss

Intraoperative blood loss in total.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

Source ClinicalTrials.gov
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