NCT03009630

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.

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
50

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2016

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

Study Start

First participant enrolled

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

December 30, 2016

Last Update Submit

January 4, 2017

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three months after ablation

Secondary Outcomes (2)

  • Progression-free survival (PFS) of participants

    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

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

Other Outcomes (1)

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

    From the time of treatment to one month after operation

Study Arms (1)

RFA group

EXPERIMENTAL

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: RFADevice: ENB

Interventions

RFAPROCEDURE

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

RFA group
ENBDEVICE

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

RFA group

Eligibility Criteria

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

You may qualify if:

  • 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

RECRUITING

Related Publications (6)

  • 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

  • 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

  • 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.

    PMID: 17646225BACKGROUND

  • 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.

    PMID: 16447018BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jiayuan Sun, MD,PhD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Sun, MD,PhD

CONTACT

86-021-22200000jysun1976@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Endoscopy Department

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 4, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)