Lung Cancer
Conditions
Keywords
Electromagnetic navigation bronchoscopy(ENB), Microwave ablation, Peripheral lung cancer
Brief summary
The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided microwave ablation (MWA) for the treatment of early-stage peripheral lung cancer.
Detailed description
The study is designed as a multi-center prospective trial with one arm. There will be 5 centers participating the study. Patients diagnosed with early-stage non-small cell lung cancer (NSCLC) that are nonsurgical candidate will be enrolled in the study. Sixty patients are expected to be enrolled in the study. The purpose of the study is to evaluate the efficacy and safety of ENB guided MWA for the treatment of patients with early-stage nonsurgical NSCLC.
Interventions
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 with peripheral lung nodules demonstrated to be NSCLC by pathology with the clinical stage of IA. 2. The length-diameter of the tumors are more than 8 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） | Three months after ablation | Tumor response will be evaluated at 3 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 |
|---|---|---|
| Arrival rate of the locatable wire | During the procedure | Disease progression is evaluated based on the changes of the tumor on computed The arrival rate is the proportion of the locatable wire reaching the location of the tumor accurately. |
| Progression-free survival (PFS) | At least 3 months | Disease progression is evaluated based on the changes of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria. |
| Overall survival (OS) | 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. |
| Complication rate | From the time of treatment to one month after ablation | 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