Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small... | NCT03108560

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

NCT03108560

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Sep 7, 2018Actual

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sublobar resection
lobectomy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2017Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Mar 28, 2017

First Submission Date that Met QC Criteria

Apr 5, 2017

First Posted Date

Apr 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2018

Last Update Posted Date

Sep 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Shanghai Zhongshan HospitalOTHER

Collaborators

Name	Class
Ruijin Hospital	OTHER
RenJi Hospital	OTHER
Fujian Medical University Union Hospital	OTHER
The Second Affiliated Hospital of Dalian Medical University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sublobar group	Experimental	Patients receive sublobar resection, including wedge resection and segmentectomy.	Procedure: sublobar resection
Lobectomy group	Active Comparator	Patients receive lobectomy.	Procedure: lobectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sublobar resection	Procedure	Patients receive sublobar resection, which includes wedge resection and segmentectomy.	Sublobar group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Junjie Xi, MD	Contact	8602164041990	2017	xi.junjie@zs-hospital.sh.cn

Overall Officials

Name	Affiliation	Role
Di Ge, MD	Fudan University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Zhongshan Hospital	Recruiting	Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D038481	Anterior Temporal Lobectomy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative
D019635	Neurosurgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided