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ENB Guided RFA for Early-stage Peripheral Lung Cancer

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

RFA

ENB

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Electromagnetic navigation bronchoscopy(ENB), Radiofrequency ablation(RFA), Peripheral lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA.
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.
Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation.
Patients have good compliance and sign the informed consent.

Exclusion Criteria:

Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
Patients have contraindications of general anesthesia.
Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion.
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.
There are large blood vessels or important structures adjacent to peripheral lung lesion.
Researchers consider the patient do not fit for the study.

Sites / Locations

Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA group

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate（ORR）of participants as assessed by the modified RECIST criteria

Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.

Secondary Outcome Measures

Progression-free survival (PFS) of participants

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.

Overall survival（OS）of participants

Overall survival（OS) is evaluated after the treatment of ablation until the patient death.

Full Information

NCT ID

NCT03009630

First Posted

December 30, 2016

Last Updated

January 4, 2017

Sponsor

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03009630

Brief Title

ENB Guided RFA for Early-stage Peripheral Lung Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Chest Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Electromagnetic navigation bronchoscopy(ENB), Radiofrequency ablation(RFA), Peripheral lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RFA group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

RFA

Intervention Description

Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.

Intervention Type

Device

Intervention Name(s)

ENB

Intervention Description

ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.

Primary Outcome Measure Information:

Title

Objective response rate（ORR）of participants as assessed by the modified RECIST criteria

Description

Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.

Time Frame

Three months after ablation

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS) of participants

Description

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.

Time Frame

From the time of treatment to the time of disease progression or death with a follow-up period of 3 years

Title

Overall survival（OS）of participants

Description

Overall survival（OS) is evaluated after the treatment of ablation until the patient death.

Time Frame

From the time of treatment to the time of the patient death with a follow-up period of 5 years

Other Pre-specified Outcome Measures:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.

Time Frame

From the time of treatment to one month after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA. 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. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation. Patients have good compliance and sign the informed consent. Exclusion Criteria: Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications. Patients have contraindications of general anesthesia. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion. 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. There are large blood vessels or important structures adjacent to peripheral lung lesion. Researchers consider the patient do not fit for the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiayuan Sun, MD,PhD

Phone

86-021-22200000

Ext

1521

jysun1976@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiayuan Sun, MD,PhD

Organizational Affiliation

Shanghai Chest Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Chest Hospital

City

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiayuan Sun, MD,PhD

Phone

18017321598

jysun1976@163.com

First Name & Middle Initial & Last Name & Degree

Jiayuan Sun, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27292045

Citation

Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10.

Results Reference

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PubMed Identifier

26044954

Citation

Koizumi T, Tsushima K, Tanabe T, Agatsuma T, Yokoyama T, Ito M, Kanda S, Kobayashi T, Yasuo M. Bronchoscopy-Guided Cooled Radiofrequency Ablation as a Novel Intervention Therapy for Peripheral Lung Cancer. Respiration. 2015;90(1):47-55. doi: 10.1159/000430825. Epub 2015 May 30.

Results Reference

background

PubMed Identifier

15746749

Citation

Fernando HC, De Hoyos A, Landreneau RJ, Gilbert S, Gooding WE, Buenaventura PO, Christie NA, Belani C, Luketich JD. Radiofrequency ablation for the treatment of non-small cell lung cancer in marginal surgical candidates. J Thorac Cardiovasc Surg. 2005 Mar;129(3):639-44. doi: 10.1016/j.jtcvs.2004.10.019.

Results Reference

background

PubMed Identifier

26096694

Citation

Dupuy DE, Fernando HC, Hillman S, Ng T, Tan AD, Sharma A, Rilling WS, Hong K, Putnam JB. Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: Results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial. Cancer. 2015 Oct 1;121(19):3491-8. doi: 10.1002/cncr.29507. Epub 2015 Jun 19.

Results Reference

background

PubMed Identifier

17646225

Citation

Anantham D, Feller-Kopman D, Shanmugham LN, Berman SM, DeCamp MM, Gangadharan SP, Eberhardt R, Herth F, Ernst A. Electromagnetic navigation bronchoscopy-guided fiducial placement for robotic stereotactic radiosurgery of lung tumors: a feasibility study. Chest. 2007 Sep;132(3):930-5. doi: 10.1378/chest.07-0522. Epub 2007 Jul 23.

Results Reference

background

PubMed Identifier

16447018

Citation

Harms W, Krempien R, Grehn C, Hensley F, Debus J, Becker HD. Electromagnetically navigated brachytherapy as a new treatment option for peripheral pulmonary tumors. Strahlenther Onkol. 2006 Feb;182(2):108-11. doi: 10.1007/s00066-006-1503-2.

Results Reference

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ENB Guided RFA for Early-stage Peripheral Lung Cancer

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