Navigation Bronchoscopy Guided Microwave Ablation Versus SBRT in Early NSCLC

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Navigation Bronchoscopy-Guided Microwave Ablation
  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.
• Лучевая терапия Stereotactic Body Radiotherapy (SBRT)
  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.

Первичные конечные точки

• Local tumour control [Срок оценки: 24 months after treatment]

Вторичные конечные точки (7)

• Local Tumour Progression-Free Survival [Срок оценки: 12 months post-treatment]
• Progression-Free Survival [Срок оценки: 12 months post-treatment]
• Overall Survival [Срок оценки: 12 months post-treatment]
• Treatment-Related Toxicity [Срок оценки: Up to 12 months post-treatment]
• Serious Adverse Events [Срок оценки: Up to 12 months post-treatment]
• Quality of Life [Срок оценки: Baseline to 12 months post-treatment]
• Healthcare Utilisation [Срок оценки: Up to 12 months post-treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT07722182 · 2026.364

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗