Clinical trial NCT02972177: Transbronchial Ablation for Peripheral Lung Tumor
Official title: Clinical Study of Navigation Bronchoscopy Guided Ablation for the Treatment of Peripheral Lung Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Transbronchial ablation
Radiofrequency ablation
Microwave ablation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local control rate
timeFrame: Three months after ablation
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From the time of treatment to the time of disease progression or death, assessed up to 1 year
measure: Overall survival（OS）
timeFrame: From the time of treatment to the time of the patient death, assessed up to 3 years
measure: Cancer-specific survival
timeFrame: From the time of treatment to the time of the patient death, assessed up to 3 years
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE 4.0
timeFrame: From the time of treatment to the complication occured, assessed up to 1 month
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: 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.
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.
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: 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.
citation: 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.