Clinical trial NCT03009630: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Electromagnetic navigation bronchoscopy(ENB)
Radiofrequency ablation(RFA)
Peripheral lung cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate（ORR）of participants as assessed by the modified RECIST criteria
timeFrame: Three months after ablation
Secondary outcomes:
measure: Progression-free survival (PFS) of participants
timeFrame: From the time of treatment to the time of disease progression or death with a follow-up period of 3 years
measure: Overall survival（OS）of participants
timeFrame: From the time of treatment to the time of the patient death with a follow-up period of 5 years
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: From the time of treatment to one month after operation
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.