Background: Stereotactic body radiotherapy (SBRT) is a standard definitive local therapy for medically inoperable early stage non-small cell lung cancer (NSCLC). Navigation bronchoscopy guided microwave ablation is an emerging alternative that may reduce treatment burden and avoid ionising radiation. However, comparative evidence against SBRT remains limited. Objective: To generate relevant comparative evidence to inform treatment selection for medically inoperable patients or patients who decline surgery with early-stage NSCLC. Methods: This is a Hong Kong led, pragmatic, multicentre, parallel group randomised controlled clinical trial with open label treatment delivery and blinded end point assessment. Eligible participants will be randomised one to one to navigation bronchoscopy guided microwave ablation or SBRT. Surveillance includes scheduled chest computed tomography at 1, 3, 6, 12, 18, and 24 months, with independent blinded imaging adjudication using a prespecified review charter. The primary end point is 24-month local tumour control, defined as absence of local progression of the treated lesion. The primary analysis will follow intention to treat and will test noninferiority using an absolute risk difference margin of 0.15. Secondary outcomes include time to local progression, progression free survival, overall survival, treatment related toxicity and serious adverse events, patient reported outcomes including quality of life trajectories, and healthcare utilisation such as hospital visits, unplanned admissions, and retreatment. The target sample size is 100 participants, providing adequate power for the prespecified noninferiority margin and supporting secondary outcome estimation. Impact: Findings will directly inform multidisciplinary decision making, local pathway design, and service planning in Hong Kong and collaborating centres.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Bronchoscopic delivery of microwave thermal energy to ablate the target lung lesion using navigation bronchoscopy guidance. Treatment will be performed according to institutional standards, including navigational planning, intraprocedural imaging, and standard perioperative care.
High-precision external beam radiotherapy delivered in a limited number of fractions to the target lung lesion according to institutional and standard-of-care radiation oncology protocols.
Prince of Wales Hospital
Hong Kong, Hong Kong
Local tumour control
defined as absence of radiological local progression of the treated lesion
Time frame: 24 months after treatment
Local Tumour Progression-Free Survival
Time from treatment initiation to local tumour progression or death from any cause.
Time frame: 12 months post-treatment
Progression-Free Survival
Time from treatment initiation to disease progression (local or distant) or death from any cause.
Time frame: 12 months post-treatment
Overall Survival
Time from treatment initiation to death from any cause.
Time frame: 12 months post-treatment
Treatment-Related Toxicity
Incidence and severity of treatment-related toxicities graded according to CTCAE version 5.0.
Time frame: Up to 12 months post-treatment
Serious Adverse Events
Number of participants experiencing serious adverse events (SAEs).
Time frame: Up to 12 months post-treatment
Quality of Life
Change in patient-reported quality of life scores measured using \[questionnaire name, e.g., EORTC QLQ-C30\].
Time frame: Baseline to 12 months post-treatment
Healthcare Utilisation
Number of hospital visits, unplanned hospital admissions, and retreatment episodes following treatment.
Time frame: Up to 12 months post-treatment
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