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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

sublobar resection

lobectomy

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring sublobar resection, lobectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sublobar group

Lobectomy group

Arm Description

Patients receive sublobar resection, including wedge resection and segmentectomy.

Patients receive lobectomy.

Outcomes

Primary Outcome Measures

Overall Survival

survival status of patients after surgery

Secondary Outcome Measures

Disease Free Survival

recurrence status of patients after surgery

Local and distant recurrence rates

recurrence rate of local and distant locations respectively

Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter

FEV1 of patients after surgery

Pulmonary Function: forced vital capacity (FVC) in liter

FVC of patients after surgery

Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg

DLCO of patients after surgery

Morbidity rate

the rates of complications related to treatment during perioperative period

Mortality rate

the rates of death related to treatment during perioperative period

Full Information

NCT ID

NCT03108560

First Posted

March 28, 2017

Last Updated

September 5, 2018

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Ruijin Hospital, RenJi Hospital, Fujian Medical University Union Hospital, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03108560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Recruiting

Study Start Date

April 18, 2017 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

sublobar resection, lobectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sublobar group

Arm Type

Experimental

Arm Description

Patients receive sublobar resection, including wedge resection and segmentectomy.

Arm Title

Lobectomy group

Arm Type

Active Comparator

Arm Description

Patients receive lobectomy.

Intervention Type

Procedure

Intervention Name(s)

sublobar resection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

lobectomy

Intervention Description

patients receive lobectomy

Primary Outcome Measure Information:

Title

Overall Survival

Description

survival status of patients after surgery

Time Frame

five years after surgery

Secondary Outcome Measure Information:

Title

Disease Free Survival

Description

recurrence status of patients after surgery

Time Frame

five years after surgery

Title

Local and distant recurrence rates

Description

recurrence rate of local and distant locations respectively

Time Frame

five years after surgery

Title

Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter

Description

FEV1 of patients after surgery

Time Frame

3rd, 6th, 12th, and 24th month after surgery

Title

Pulmonary Function: forced vital capacity (FVC) in liter

Description

FVC of patients after surgery

Time Frame

3rd, 6th, 12th, and 24th month after surgery

Title

Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg

Description

DLCO of patients after surgery

Time Frame

3rd, 6th, 12th, and 24th month after surgery

Title

Morbidity rate

Description

the rates of complications related to treatment during perioperative period

Time Frame

up to 30 days after surgery

Title

Mortality rate

Description

the rates of death related to treatment during perioperative period

Time Frame

up to 30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junjie Xi, MD

Phone

8602164041990

Ext

2017

xi.junjie@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Di Ge, MD

Organizational Affiliation

Fudan University

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Zhongshan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Di Ge, MD

Phone

13681975917

ge.di@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data of all case report forms are to be collected and shared with other researchers at the end of followup.

Learn more about this trial

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

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