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Transbronchial Ablation for Peripheral Lung Tumor

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Radiofrequency ablation

Microwave ablation

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, Transbronchial ablation, Radiofrequency ablation, Microwave ablation

Eligibility Criteria

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

Inclusion Criteria:

Patients older than 18 year-old.
Patients meeting one of the following criteria: 1) patients discovered with peripheral lung lesions that have demonstrated to be lung cancer by pathology with the clinical stage no later than IIA. 2) recurrent or progressive single lesion or solitary intrapulmonary metastasis after surgery, radiotherapy, chemotherapy or other treatment.3) multiple primary lung cancer with the number of tumors no more than 5 and no metastasis. 4) pulmonary metastases with effective treatment of primary disease, the number of metastases no more than 5 and no other metastasis.
Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm.
Patients are unsuitable for surgery assessed by multidisciplinary team 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 or bronchoscopy shows that guided and treatment instruments 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 due to other reasons.

Sites / Locations

Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Radiofrequency ablation group

Microwave ablation group

Arm Description

Patients with inoperable peripheral lung tumor will be performed transbronchial radiofrequency ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.

Patients with inoperable peripheral lung tumor will be performed transbronchial microwave ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure.

Outcomes

Primary Outcome Measures

Local control rate

Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.

Secondary Outcome Measures

Progression-free survival (PFS)

PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.

Overall survival（OS）

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

Cancer-specific survival

The cause of death is related to the patient's underlying malignancy.

Full Information

NCT ID

NCT02972177

First Posted

November 12, 2016

Last Updated

February 16, 2020

Sponsor

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02972177

Brief Title

Transbronchial Ablation for Peripheral Lung Tumor

Official Title

Clinical Study of Navigation Bronchoscopy Guided Ablation for the Treatment of Peripheral Lung Tumor

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 7, 2018 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for the treatment of inoperable peripheral lung tumor.

Detailed Description

The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for treating inoperable malignant lung tumor. The study is designed as a single-center prospective trial. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital,Shanghai Jiao Tong University, China. Patients are divided into two groups, including radiofrequency ablation group and microwave ablation group. Sixty patients are expected to be enrolled into the study with 30 patients in each group.

6. Conditions and Keywords

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

Lung Cancer

Keywords

Lung cancer, Transbronchial ablation, Radiofrequency ablation, Microwave ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency ablation group

Arm Type

Experimental

Arm Description

Arm Title

Microwave ablation group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation

Intervention Description

Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.

Intervention Type

Procedure

Intervention Name(s)

Microwave ablation

Intervention Description

Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.

Primary Outcome Measure Information:

Title

Local control rate

Description

Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.

Time Frame

Three months after ablation

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.

Time Frame

From the time of treatment to the time of disease progression or death, assessed up to 1 year

Title

Overall survival（OS）

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, assessed up to 3 years

Title

Cancer-specific survival

Description

The cause of death is related to the patient's underlying malignancy.

Time Frame

From the time of treatment to the time of the patient death, assessed up to 3 years

Other Pre-specified Outcome Measures:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE 4.0

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 the complication occured, assessed up to 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients older than 18 year-old. Patients meeting one of the following criteria: 1) patients discovered with peripheral lung lesions that have demonstrated to be lung cancer by pathology with the clinical stage no later than IIA. 2) recurrent or progressive single lesion or solitary intrapulmonary metastasis after surgery, radiotherapy, chemotherapy or other treatment.3) multiple primary lung cancer with the number of tumors no more than 5 and no metastasis. 4) pulmonary metastases with effective treatment of primary disease, the number of metastases no more than 5 and no other metastasis. Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm. Patients are unsuitable for surgery assessed by multidisciplinary team 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 or bronchoscopy shows that guided and treatment instruments 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 due to other reasons.

Central Contact Person:

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

Jiayuan Sun, MD,PhD

Phone

86-021-22200000-1521

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

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PubMed Identifier

23601905

Citation

Jahangeer S, Forde P, Soden D, Hinchion J. Review of current thermal ablation treatment for lung cancer and the potential of electrochemotherapy as a means for treatment of lung tumours. Cancer Treat Rev. 2013 Dec;39(8):862-71. doi: 10.1016/j.ctrv.2013.03.007. Epub 2013 Apr 17.

Results Reference

background

PubMed Identifier

18651356

Citation

Wasser EJ, Dupuy DE. Microwave ablation in the treatment of primary lung tumors. Semin Respir Crit Care Med. 2008 Aug;29(4):384-94. doi: 10.1055/s-2008-1081281.

Results Reference

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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

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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

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PubMed Identifier

26273346

Citation

Ye X, Fan W, Chen JH, Feng WJ, Gu SZ, Han Y, Huang GH, Lei GY, Li XG, Li YL, Li ZJ, Lin ZY, Liu BD, Liu Y, Peng ZM, Wang H, Yang WW, Yang X, Zhai B, Zhang J. Chinese expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors. Thorac Cancer. 2015 Jan;6(1):112-21. doi: 10.1111/1759-7714.12152. Epub 2015 Jan 7.

Results Reference

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PubMed Identifier

35166043

Citation

Xie F, Chen J, Jiang Y, Sun J, Hogarth DK, Herth FJF. Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study. Thorac Cancer. 2022 Apr;13(7):1014-1020. doi: 10.1111/1759-7714.14351. Epub 2022 Feb 14.

Results Reference

derived

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Transbronchial Ablation for Peripheral Lung Tumor

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