Endoscopic Nodal Staging in Oligometastatic Non-small Cell Lung Cancer (NSCLC) Being Treated With Stereotactic Ablative Radiotherapy (ENDO-SABR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Changes to treatment intent and/or plan
研究概览
简要总结
This study will investigate the role of sampling suspicious chest lymph nodes with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) in patients planned to receive radical dose radiation.
This study will use Stereotactic Ablative Radiotherapy (SABR) for treatment methods. SABR is a newer radiation treatment that delivers high-dose, precise radiation to small tumors and can be delivered more accurately than with older radiation treatment methods. It is considered a standard treatment for small lung cancers, and select cancers that have spread to the brain.
The purpose of this study is to compare if the lymph node sampling procedure is valuable for determining the extend of nodal disease in metastatic Non-Small Cell Lung Cancer (NSCLC) compared to imaging alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with oligometastatic non-small cell lung cancer (NSCLC), including a primary lung tumour (± hilar/mediastinal adenopathy) with up to 5 synchronous metastases
- •Radical treatment intent to all sites is recommended at multi-disciplinary tumour board or by discussion by medical oncologist and radiation oncologist and/or surgeon.
- •Age 18 years or older
- •Good performance status (Eastern Cooperative Oncology Group [ECOG 0-1) with life-expectancy of at least 6 months as determined by enrolling physician
- •Patient has undergone staging investigations less than 3 months prior to registration.
- •Positron Emission Tomography (PET) / Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) brain (CT brain with contrast if contraindication to MRI) OR
- •CT chest/abdomen, radionucleotide bone scan and MRI of brain (CT brain with contrast if contraindication to MRI)
- •Pathologic confirmation of NSCLC
排除标准
- •Contraindication to Endobronchial Ultrasound (EBUS) / Endoscopic Ultrasound (EUS)
- •Unable to provide consent for EBUS/EUS
- •Contraindication to chest radiotherapy
- •Pregnant or lactating women
研究组 & 干预措施
Treatment Arm
Small pieces of suspicious chest lymph nodes will be removed with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA).
干预措施: Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) (Procedure)
Treatment Arm
Small pieces of suspicious chest lymph nodes will be removed with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA).
干预措施: Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA) (Procedure)
结局指标
主要结局
Changes to treatment intent and/or plan
时间窗: 2 years
Number of patients whose treatment is changed from stereotactic ablative radiotherapy (SABR) to conventional dose radiation, change in mediastinal radiation field, change from curative intent to palliative intent treatment
次要结局
- Determine the proportion of patients with occult mediastinal metastasis(2 years)
- Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes(2 years)
- Determine the proportion of patients with complications of endoscopic procedure(2 years)
- Identify the total number of lymph nodes sampled per procedure(2 years)
- Identify the nodal stations sampled(2 years)