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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Shanghai Chest Hospital
Shanghai, China
RECRUITINGObjective 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.
Time frame: Three months after ablation
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.
Time frame: From the time of treatment to the time of disease progression or death with a follow-up period of 3 years
Overall survival(OS)of participants
Overall survival(OS) is evaluated after the treatment of ablation until the patient death.
Time frame: From the time of treatment to the time of the patient death with a follow-up period of 5 years
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