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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENB-guided ablation therapy combined with VATS | Procedure | After receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who meet inclusion/exclusion will be enrolled in the study consecutively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD, PhD | Contact | +86-021-22200000 | 1511 | xkyyjysun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD, PhD | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23649443 | Background | 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. | |
| 25700387 | Background |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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| 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. |
| 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. |
| 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. |
| 29970646 | Background | 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. |
| 27292045 | Background | 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. |
| 17360727 | Background | 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. doi: 10.1183/09031936.00111306. Epub 2007 Mar 14. |
| 19858232 | Background | 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. |
| 28683443 | Background | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |