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

A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108560
Enrollment
600
Registered
2017-04-11
Start date
2017-04-18
Completion date
2023-12-31
Last updated
2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

sublobar resection, lobectomy

Brief summary

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.

Interventions

PROCEDUREsublobar resection

Patients receive sublobar resection, which includes wedge resection and segmentectomy.

PROCEDURElobectomy

patients receive lobectomy

Sponsors

Ruijin Hospital
CollaboratorOTHER
RenJi Hospital
CollaboratorOTHER
Fujian Medical University Union Hospital
CollaboratorOTHER
The Second Affiliated Hospital of Dalian Medical University
CollaboratorOTHER
First Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER
Ningbo No.2 Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survivalfive years after surgerysurvival status of patients after surgery

Secondary

MeasureTime frameDescription
Local and distant recurrence ratesfive years after surgeryrecurrence rate of local and distant locations respectively
Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter3rd, 6th, 12th, and 24th month after surgeryFEV1 of patients after surgery
Pulmonary Function: forced vital capacity (FVC) in liter3rd, 6th, 12th, and 24th month after surgeryFVC of patients after surgery
Disease Free Survivalfive years after surgeryrecurrence status of patients after surgery
Morbidity rateup to 30 days after surgerythe rates of complications related to treatment during perioperative period
Mortality rateup to 30 days after surgerythe rates of death related to treatment during perioperative period
Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg3rd, 6th, 12th, and 24th month after surgeryDLCO of patients after surgery

Countries

China

Contacts

Primary ContactJunjie Xi, MD
xi.junjie@zs-hospital.sh.cn8602164041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026