ENB-guided Ablation Therapy Combined With VATS in the Treatment of MPLC

Lung Cancer Clinical Trial

Official title:

Electromagnetic Navigation Bronchoscopy Guided Ablation Therapy Combined With VATS in the Treatment of Multiple Primary Lung Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730453
• Other study ID #: SHCHE202101
• Status: Recruiting
• Start date: July 24, 2020
• Est. completion date: December 2025

Study information

• Verified date: January 2021
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD, PhD
• Phone: +86-021-22200000
• Email: xkyyjysun[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).

Description:

Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive ENB-guided ablation therapy combined with VATS. The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), overall survival (OS) and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old.

2. The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.

3. Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is = 3 cm.

4. The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.

Exclusion Criteria:

1. The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.

2. The situation in which the investigators think that the subject is not suitable to participate in this study.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• ENB-guided ablation therapy combined with VATS
After receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Ambrogi MC, Fanucchi O, Dini P, Melfi F, Davini F, Lucchi M, Massimetti G, Mussi A. Wedge resection and radiofrequency ablation for stage I nonsmall cell lung cancer. Eur Respir J. 2015 Apr;45(4):1089-97. doi: 10.1183/09031936.00188014. Epub 2015 Feb 19. — 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

Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e278S-e313S. doi: 10.1378/chest.12-2359. — View Citation

Tanabe T, Koizumi T, Tsushima K, Ito M, Kanda S, Kobayashi T, Yasuo M, Yamazaki Y, Kubo K, Honda T, Kondo R, Yoshida K. Comparative study of three different catheters for CT imaging-bronchoscopy-guided radiofrequency ablation as a potential and novel interventional therapy for lung cancer. Chest. 2010 Apr;137(4):890-7. doi: 10.1378/chest.09-1065. Epub 2009 Oct 26. — View Citation

Tsushima K, Koizumi T, Tanabe T, Nakagawa R, Yoshikawa S, Yasuo M, Kubo K. Bronchoscopy-guided radiofrequency ablation as a potential novel therapeutic tool. Eur Respir J. 2007 Jun;29(6):1193-200. Epub 2007 Mar 14. — View Citation

Xie F, Zheng X, Xiao B, Han B, Herth FJF, Sun J. Navigation Bronchoscopy-Guided Radiofrequency Ablation for Nonsurgical Peripheral Pulmonary Tumors. Respiration. 2017;94(3):293-298. doi: 10.1159/000477764. Epub 2017 Jul 6. — View Citation

Ye X, Fan W, Wang H, Wang J, Wang Z, Gu S, Feng W, Zhuang Y, Liu B, Li X, Li Y, Li C, Xiao Y, Yang P, Yang X, Yang W, Chen J, Zhang R, Lin Z, Meng Z, Hu K, Liu C, Peng Z, Han Y, Jin Y, Lei G, Zhai B, Huang G. Expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors (2018 edition). J Cancer Res Ther. 2018;14(4):730-744. doi: 10.4103/jcrt.JCRT_221_18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of ablation efficacy, ORR (objective response rate)	ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) after ablation therapy. Efficacy evaluation is based on Modifield Response Evaluation Criteria in Solid Tumors (mRECIST).	From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.
Secondary	Evaluation of ablation efficacy, PFS (progression-free survival)	PFS is defined as the time from the start of treatment to the first occurrence of disease progression or death for any cause.	From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Secondary	Evaluation of ablation efficacy, OS (overall survival)	OS is defined as the time from the start of treatment to the death of the patient.	From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Secondary	Observation of complications of ablation	Complications refer to the combination of serious adverse events related to the operation during or after the operation, mainly including pneumothorax and bleeding.	From date of treatment to the one month after ablation.