Investigation of the Efficacy of Local Minimally Invasive Ablative Therapy for Pulmonary Tumors and Its Impact on Respiratory Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Local oncologic control
研究概览
简要总结
This clinical study is evaluating different treatment options for patients with malignant lung tumors, including both primary lung cancer and tumors that have spread to the lungs from other parts of the body. The goal is to compare the safety, effectiveness, and quality-of-life impact of three approaches: surgery, stereotactic body radiotherapy (SBRT), and minimally invasive thermal ablation (microwave or cryoablation).
Thermal ablation is a procedure in which a small antenna is inserted through the skin into the tumor and the cancer cells are destroyed using heat or freezing. SBRT uses precisely targeted radiation to destroy tumors, while surgery involves removing part of the lung. These methods are already used in routine care, but this study directly compares them to understand which patients may benefit most from each approach.
In addition to cancer control, the study is measuring how these treatments affect breathing function. Patients will have regular follow-up visits with CT scans, breathing tests, and blood draws for up to two years.
About 100 adults in Lithuania are expected to participate. The results will help doctors make better treatment recommendations, balancing cancer control with patient well-being, lung function, and quality of life.
详细描述
Lung cancer remains one of the leading causes of cancer-related death worldwide, and the lungs are also a common site of metastases from other cancers such as colorectal, breast, or kidney tumors. While surgery is considered the gold standard for treatment of early-stage lung cancer and resectable pulmonary metastases, many patients are not suitable surgical candidates due to age, comorbidities, or personal choice. For these patients, less invasive treatments such as stereotactic body radiotherapy (SBRT) or image-guided thermal ablation may provide effective alternatives.
This study is designed to evaluate the safety, effectiveness, and patient-centered outcomes of three treatment strategies for malignant lung tumors:
- Surgery (anatomical lung resection, when feasible)
- Stereotactic body radiotherapy (SBRT), which delivers high doses of precisely targeted radiation
- Minimally invasive thermal ablation, performed under CT guidance using microwave or cryoablation technology to destroy tumor tissue with heat or freezing
Thermal ablation and SBRT are established treatment options in many centers worldwide, but there is limited prospective data directly comparing these modalities with surgery. This trial aims to address that gap by examining not only oncologic outcomes such as recurrence, survival, and complications, but also functional and quality-of-life outcomes.
Study Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Adults (18 years or older)
- •Verified systemic therapy-naive biopsy-proven NSCLC, stages from Tis to T2; or oligometastatic peripheral (≤ 5 lesions) lung disease;
- •All lesions are ≤3 cm in size and accessible for surgery, ablation or SBRT;
- •No local nodal or distant metastatic disease on diagnostic imaging;
- •Documented agreement on the recommended curative treatment by a multidisciplinary team, including a pulmonologist, interventional radiologist, radiation therapist, thoracic surgeon, and oncologist;
- •Documented patient's agreement to receive the intended therapy and to participate in this study via a signed informed consent form.
排除标准
- •Central lung tumors (<2 cm from the main bronchi or hilum);
- •>5 or diffuse lung lesions, or prior local treatment to the same lesion;
- •Major comorbidities, physical or social limitations precluding trial participation;
- •Contraindications to general anesthesia, inability to temporarily withdraw antiplatelet therapy, or evidence of severe coagulopathy.
结局指标
主要结局
Local oncologic control
时间窗: Up to 24 months after treatment.
Evaluate and compare local relapse rates on CT or PET/CT imaging following surgery, stereotactic body radiotherapy (SBRT), or thermal ablation. Local disease control is the central measure of treatment effectiveness.
次要结局
- Complication Rates(Immediately post-treatment and throughout the 24-month follow-up.)
- Respiratory Function: gas diffusion(Baseline before treatment and 3-12 months post-treatment.)
- Disease Recurrence(Up to 24 months after treatment.)
- Respiratory Function: spirometry(Baseline before treatment and 3-12 months post-treatment.)
- Survival(Up to 24 months after treatment)
- Hospitalization(From the date of treatment until the date of discharge, assessed up to 24 months)
- Respiratory Function: lung perfusion scintigraphy(Baseline before treatment and 3-12 months post-treatment.)
- Health-Related Quality of Life(At baseline and one month post-treatment.)
研究者
Aurimas Macionis
Principal Investigator
Lithuanian University of Health Sciences