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.
Inclusion Criteria:
1. Adults aged 18 years or above. 2. Clinically stage IA NSCLC suitable for definitive local therapy, defined as T1N0M0 with maximum tumour diameter 3 cm or less, based on routine staging work up and multidisciplinary team review.
3. Pathological confirmation of NSCLC by histology or cytology whenever feasible. If tissue confirmation is not feasible or poses unacceptable risk, eligibility may be allowed after multidisciplinary consensus that imaging and clinical features are highly consistent with primary lung cancer, consistent with SBRT guidance for selected unbiopsied cases.
4. Medically inoperable status, or patient declines surgery after multidisciplinary discussion, and both navigation bronchoscopy-guided microwave ablation and SBRT are considered acceptable treatment options by the treating teams (clinical equipoise).
5. Target lesion technically suitable for both modalities, including feasibility and safety for bronchoscopy-based ablation and suitability for SBRT planning and delivery.
6. Willing and able to provide informed consent and accept random assignment to either navigation bronchoscopy guided microwave ablation or SBRT, and able to comply with the follow up schedule.
Exclusion Criteria:
1. Evidence of lymph node involvement (N1 or higher) or distant metastases (M1) on routine staging.
2. Multiple synchronous primary lung cancers requiring different local strategies, or inability to define a single index lesion for primary endpoint assessment.
3. Prior thoracic radiotherapy that would overlap the planned SBRT field, or prior local therapy to the index lesion.
4. Another active malignancy that is likely to confound outcome assessment (for example, malignancy requiring systemic therapy or expected to limit 2-year survival), except adequately treated non melanoma skin cancer or in situ carcinoma with negligible recurrence risk. 5. Contraindications to bronchoscopy sedation or anaesthesia that preclude RAB or ENB guided ablation, or medical conditions that preclude SBRT positioning or safe delivery.
6. Lesions judged unsafe or technically infeasible for either modality (for example, proximity to critical structures beyond predefined safety limits), as determined by the procedural and radiation oncology teams.
7. Pregnant or breastfeeding women. 8. Inability or unwillingness to comply with study procedures or follow up.
calvinng@surgery.cuhk.edu.hk85235052618
Participants allocated to navigation bronchoscopy-guided microwave ablation will undergo bronchoscopic ablation according to standard institutional protocols, including navigational planning, intraprocedural imaging as per routine practice, and peri procedural care pathways. Key technical parameters will be recorded prospectively to support quality assurance and prespecified secondary analyses.
Participants randomized to this arm will receive stereotactic body radiotherapy according to standard radiation oncology protocols. Treatment will include simulation, target delineation, dose prescription and fractionation per routine clinical practice, and standard toxicity monitoring. Treatment parameters will be prospectively recorded.
calvinng@surgery.cuhk.edu.hk+85291048780
Study of Robotic Assisted/Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)
SBRT (Stereotactic Body Radiation Therapy) vs. Surgery in High Risk Patients With Early Stage Lung Cancer
Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.
Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients Non-Small Lung Cancer
Radical Resection Vs. Ablative Stereotactic Radiotherapy in Patients With Operable Stage I NSCLC
LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC