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

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ClinicalTrials.gov Identifier: NCT03108560
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
Ruijin Hospital
RenJi Hospital
Fujian Medical University Union Hospital
The Second Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Wenzhou Medical Univeristy
Ningbo No.2 Hospital
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Procedure: sublobar resection Procedure: lobectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: five years after surgery ]
    survival status of patients after surgery


Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: five years after surgery ]
    recurrence status of patients after surgery

  2. Local and distant recurrence rates [ Time Frame: five years after surgery ]
    recurrence rate of local and distant locations respectively

  3. Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter [ Time Frame: 3rd, 6th, 12th, and 24th month after surgery ]
    FEV1 of patients after surgery

  4. Pulmonary Function: forced vital capacity (FVC) in liter [ Time Frame: 3rd, 6th, 12th, and 24th month after surgery ]
    FVC of patients after surgery

  5. Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg [ Time Frame: 3rd, 6th, 12th, and 24th month after surgery ]
    DLCO of patients after surgery

  6. Morbidity rate [ Time Frame: up to 30 days after surgery ]
    the rates of complications related to treatment during perioperative period

  7. Mortality rate [ Time Frame: up to 30 days after surgery ]
    the rates of death related to treatment during perioperative period



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108560


Contacts
Contact: Junjie Xi, MD 8602164041990 ext 2017 xi.junjie@zs-hospital.sh.cn

Locations
China, Shanghai
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Di Ge, MD    13681975917    ge.di@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Ruijin Hospital
RenJi Hospital
Fujian Medical University Union Hospital
The Second Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Wenzhou Medical Univeristy
Ningbo No.2 Hospital
Investigators
Study Chair: Di Ge, MD Fudan University

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03108560     History of Changes
Other Study ID Numbers: ZSTS201701
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data of all case report forms are to be collected and shared with other researchers at the end of followup.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Zhongshan Hospital:
sublobar resection
lobectomy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases