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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108560
• Other study ID #: ZSTS201701
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Junjie Xi, MD
• Phone: 8602164041990
• Email: xi.junjie[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Procedure:
• sublobar resection
Patients receive sublobar resection, which includes wedge resection and segmentectomy.
• lobectomy
patients receive lobectomy

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	First Affiliated Hospital of Wenzhou Medical Univeristy, Fujian Medical University Union Hospital, Ningbo No.2 Hospital, RenJi Hospital, Ruijin Hospital, The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	survival status of patients after surgery	five years after surgery
Secondary	Disease Free Survival	recurrence status of patients after surgery	five years after surgery
Secondary	Local and distant recurrence rates	recurrence rate of local and distant locations respectively	five years after surgery
Secondary	Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter	FEV1 of patients after surgery	3rd, 6th, 12th, and 24th month after surgery
Secondary	Pulmonary Function: forced vital capacity (FVC) in liter	FVC of patients after surgery	3rd, 6th, 12th, and 24th month after surgery
Secondary	Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg	DLCO of patients after surgery	3rd, 6th, 12th, and 24th month after surgery
Secondary	Morbidity rate	the rates of complications related to treatment during perioperative period	up to 30 days after surgery
Secondary	Mortality rate	the rates of death related to treatment during perioperative period	up to 30 days after surgery