Transbronchial Ablation for Peripheral Lung Tumor

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02972177
• Other study ID #: SHCHE201603
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD,PhD
• Phone: 86-021-22200000-1521
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients older than 18 year-old.

2. 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.

3. Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm.

4. Patients are unsuitable for surgery assessed by multidisciplinary team and agree to the primary treatment of ablation.

5. 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 or bronchoscopy shows that guided and treatment instruments cannot reach the peripheral lung lesion.

4. There are large blood vessels or important structures adjacent to peripheral lung lesion.

5. Researchers consider the patient do not fit for the study due to other reasons.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Radiofrequency ablation
Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.
• Microwave ablation
Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.

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 (7)

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. — 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

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. Review. — View 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. 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. Epub 2015 May 30. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by CTCAE 4.0	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 the complication occured, assessed up to 1 month
Primary	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	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.	From the time of treatment to the time of disease progression or death, assessed up to 1 year
Secondary	Overall survival(OS)	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, assessed up to 3 years
Secondary	Cancer-specific survival	The cause of death is related to the patient's underlying malignancy.	From the time of treatment to the time of the patient death, assessed up to 3 years