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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Procedure: sublobar resection; Procedure: lobectomy

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junjie Xi, MD; Phone Number: 2017 8602164041990; Email: xi.junjie@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Di Ge, MD; Phone Number: 13681975917; Email: ge.di@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sublobar group; Patients receive sublobar resection, including wedge resection and segmentectomy.	Procedure: sublobar resection; Patients receive sublobar resection, which includes wedge resection and segmentectomy.
ACTIVE_COMPARATOR: Lobectomy group; Patients receive lobectomy.	Procedure: lobectomy; patients receive lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	survival status of patients after surgery	five years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity rate	the rates of complications related to treatment during perioperative period	up to 30 days after surgery
Mortality rate	the rates of death related to treatment during perioperative period	up to 30 days after surgery
Disease Free Survival	recurrence status of patients after surgery	five years after surgery
Local and distant recurrence rates	recurrence rate of local and distant locations respectively	five years after surgery
Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter	FEV1 of patients after surgery	3rd, 6th, 12th, and 24th month after surgery
Pulmonary Function: forced vital capacity (FVC) in liter	FVC of patients after surgery	3rd, 6th, 12th, and 24th month after surgery
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: RenJi Hospital; Ruijin Hospital; Fujian Medical University Union Hospital; First Affiliated Hospital of Wenzhou Medical University; Ningbo No.2 Hospital; The Second Affiliated Hospital of Dalian Medical University
• Investigators: Study Chair: Di Ge, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2017
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (ACTUAL): April 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: lobectomy; sublobar resection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ZSTS201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data of all case report forms are to be collected and shared with other researchers at the end of followup.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No