NCT03108560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

6.7 years

First QC Date

March 28, 2017

Last Update Submit

September 5, 2018

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

sublobar resectionlobectomy

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    survival status of patients after surgery

    five years after surgery

Secondary Outcomes (7)

  • Disease Free Survival

    five years after surgery

  • Local and distant recurrence rates

    five years after surgery

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

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

  • Pulmonary Function: forced vital capacity (FVC) in liter

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

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

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

  • +2 more secondary outcomes

Study Arms (2)

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

sublobar resectionPROCEDURE

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

Sublobar group
lobectomyPROCEDURE

patients receive lobectomy

Lobectomy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Di Ge, MD

    Fudan University

    STUDY CHAIR

Central Study Contacts

Junjie Xi, MD

CONTACT

8602164041990xi.junjie@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 11, 2017

Study Start

April 18, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

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

Locations

CN(1)