Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer

Fudan University

Status: Unknown

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Procedure: sublobar resection; Procedure: lobectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03108560

ZSTS201701

Details and patient eligibility

About

The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cT1N0M0 non-small-cell lung cancer
• ground-glass opacity, ≤2cm, GGO≥25%
• eligible for both lobectomy and sublobar resection
• intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma
• intraoperative pathology of biopsied station 10 lymph node is negative

Exclusion criteria

• intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ
• intraoperative pathology of biopsied station 10 lymph node is positive
• multiple GGOs, lesions other than dominant lesion are malignant or >5mm
• history of thoracic surgery
• history of malignancy in recent 5 years
• unstable systemic disease
• patients with psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Sublobar group

Experimental group

Description:

Patients receive sublobar resection, including wedge resection and segmentectomy.

Treatment:

Procedure: sublobar resection

Lobectomy group

Active Comparator group

Description:

Patients receive lobectomy.

Treatment:

Procedure: lobectomy