A Pragmatic Randomised Trial Comparing Navigation Bronchoscopy-guided Microwave Ablation Versus Stereotactic Body Radiotherapy for Medically Inoperable or Surgery-declining Early-stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Local tumour control
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults aged 18 years or above.
- •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.
排除标准
- •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.
- •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.
- •Inability or unwillingness to comply with study procedures or follow up.
研究组 & 干预措施
navigation bronchoscopy-guided microwave ablation
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.
干预措施: Navigation Bronchoscopy-Guided Microwave Ablation (Procedure)
Stereotactic Body Radiotherapy (SBRT)
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.
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
Local tumour control
时间窗: 24 months after treatment
defined as absence of radiological local progression of the treated lesion
次要结局
- Local tumour control(12 months post-treatment)
- Local Tumour Progression-Free Survival(12 months post-treatment)
- Progression-Free Survival(12 months post-treatment)
- Overall Survival(12 months post-treatment)
- Treatment-Related Toxicity(Up to 12 months post-treatment)
- Serious Adverse Events(Up to 12 months post-treatment)
- Quality of Life(Baseline to 12 months post-treatment)
- Healthcare Utilisation(Up to 12 months post-treatment)
研究者
Calvin Sze Hang Ng
Environmental Foundation Professor of Thoracic Surgery
Chinese University of Hong Kong