ENB Guided RFA for Early-stage Peripheral Lung Cancer

January 4, 2017 updated by: Jiayuan Sun, Shanghai Chest Hospital

The Clinical Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Radiofrequency Ablation (RFA) for the Treatment of Early-stage Peripheral Lung Cancer

The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of early-stage peripheral lung cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is aimed to evaluate the efficacy and safety of ENB guided RFA for the treatment of patients with early-stage non-small cell lung cancer (NSCLC). The study is designed as a single-center prospective trial with one arm. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, China. Patients diagnosed with early-stage NSCLC will be enrolled into the study. Fifty patients are expected to be enrolled totally.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA.
  2. The tumors are solid or part-solid peripheral lung nodules and the length-diameter of the nodules are more than 10 mm and no more than 30 mm.
  3. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation.
  4. Patients have good compliance and sign the informed consent.

Exclusion Criteria:

  1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
  2. Patients have contraindications of general anesthesia.
  3. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion.
  4. Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion.
  5. There are large blood vessels or important structures adjacent to peripheral lung lesion.
  6. Researchers consider the patient do not fit for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RFA group
Patients with early-stage peripheral lung cancer will be performed RFA with the guidance of ENB. Post treatment response and follow up will be evaluated and carried out according to the standard procedure.
Procedure: RFA
Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.
Device: ENB
ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate（ORR）of participants as assessed by the modified RECIST criteria
Time Frame: Three months after ablation
Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.
Three months after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) of participants
Time Frame: From the time of treatment to the time of disease progression or death with a follow-up period of 3 years
Disease progression is evaluated by the variation of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria.
From the time of treatment to the time of disease progression or death with a follow-up period of 3 years
Overall survival（OS）of participants
Time Frame: From the time of treatment to the time of the patient death with a follow-up period of 5 years
Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
From the time of treatment to the time of the patient death with a follow-up period of 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: From the time of treatment to one month after operation
Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.
From the time of treatment to one month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (ESTIMATE)

January 4, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCHE201604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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