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

NCT ID: NCT03108560

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublobar group

Patients receive sublobar resection, including wedge resection and segmentectomy.

Group Type EXPERIMENTAL

sublobar resection

Intervention Type PROCEDURE

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

Lobectomy group

Patients receive lobectomy.

Group Type ACTIVE_COMPARATOR

lobectomy

Intervention Type PROCEDURE

patients receive lobectomy

Interventions

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sublobar resection

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

Intervention Type PROCEDURE

lobectomy

patients receive lobectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Ningbo No.2 Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Di Ge, MD

Role: STUDY_CHAIR

Fudan University

Locations

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Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junjie Xi, MD

Role: CONTACT

8602164041990 ext. 2017

Facility Contacts

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Di Ge, MD

Role: primary

13681975917

Other Identifiers

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ZSTS201701

Identifier Type: -

Identifier Source: org_study_id

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