Lung Cancer
Conditions
Keywords
Electromagnetic navigation bronchoscopy(ENB), Radiofrequency ablation(RFA), Peripheral lung cancer
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERFA
Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.
DEVICEENB
ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA. 2. The tumors are solid or part-solid peripheral lung nodules and the length-diameter of the nodules are more than 10 mm and no more than 30 mm. 3. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation. 4. 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 suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion. 4. Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion. 5. There are large blood vessels or important structures adjacent to peripheral lung lesion. 6. Researchers consider the patient do not fit for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate（ORR）of participants as assessed by the modified RECIST criteria | Three months after ablation | Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) of participants | From the time of treatment to the time of disease progression or death with a follow-up period of 3 years | 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. |
| Overall survival（OS）of participants | From the time of treatment to the time of the patient death with a follow-up period of 5 years | Overall survival（OS) is evaluated after the treatment of ablation until the patient death. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From the time of treatment to one month after operation | Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection. |
Countries
China
Contacts
Primary ContactJiayuan Sun, MD,PhD
Outcome results
None listed