ENB Guided RFA for Early-stage Peripheral Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009630
• Other study ID #: SHCHE201604
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2016
• Last updated: January 4, 2017
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2017
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD,PhD
• Phone: 86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2016 Jun 9. pii: S0012-3692(16)49258-5. doi: 10.1016/j.chest.2016.05.025. [Epub ahead of print] Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.	From the time of treatment to one month after operation	Yes
Primary	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	No
Secondary	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.	From the time of treatment to the time of disease progression or death with a follow-up period of 3 years	No
Secondary	Overall survival(OS)of participants	Overall survival(OS) is evaluated after the treatment of ablation until the patient death.	From the time of treatment to the time of the patient death with a follow-up period of 5 years	No