NCT02972177

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.

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
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable lung-cancer

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

November 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

2.8 years

First QC Date

November 12, 2016

Last Update Submit

February 16, 2020

Conditions

Lung Cancer

Keywords

Lung cancerTransbronchial ablationRadiofrequency ablationMicrowave ablation

Outcome Measures

Primary Outcomes (1)

  • Local control rate

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

    Three months after ablation

Secondary Outcomes (3)

  • Progression-free survival (PFS)

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

  • Overall survival（OS）

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

  • Cancer-specific survival

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

Other Outcomes (1)

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

    From the time of treatment to the complication occured, assessed up to 1 month

Study Arms (2)

Radiofrequency ablation group

EXPERIMENTAL

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.

Procedure: Radiofrequency ablation

Microwave ablation group

EXPERIMENTAL

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.

Procedure: Microwave ablation

Interventions

Radiofrequency ablationPROCEDURE

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

Radiofrequency ablation group
Microwave ablationPROCEDURE

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

Microwave ablation group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 27292045BACKGROUND

  • 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.

    PMID: 26044954BACKGROUND

  • 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.

    PMID: 23601905BACKGROUND

  • 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.

    PMID: 18651356BACKGROUND

  • 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.

    PMID: 15746749BACKGROUND

  • 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.

    PMID: 26096694BACKGROUND

  • 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.

    PMID: 26273346BACKGROUND

  • 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.

    PMID: 35166043DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Jiayuan Sun, MD,PhD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Sun, MD,PhD

CONTACT

86-021-22200000-1521jysun1976@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Endoscopy

Study Record Dates

First Submitted

November 12, 2016

First Posted

November 23, 2016

Study Start

February 7, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)