Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver - a Randomized Phase II Trail
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Freedom from local lesion progression (analyzed on patient-level)
研究概览
简要总结
The LAVA-CRLM trial (Local Ablation Versus Ablative radiotherapy in ColoRectal Liver Metastases) is a prospective, randomised, phase 2 study designed to compare local control and safety of microwave ablation (MWA) versus stereotactic body radiotherapy (SBRT)in patients with colorectal liver metastases and oligometastatic disease. Primary endpoint is freedom form local lesion progression.
详细描述
Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.
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
- •Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of
- •non-resectability
- •small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
- •previous extensive liver surgery
- •comorbidity
- •The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
- •Tumor sizes ≤4.0 cm
- •Age > 18 years
- •Signed informed consent
排除标准
- •Previous radiotherapy to the liver
- •Liver volume < 700 ml
- •Another active cancer disease within the past 36 months
- •Not able to understand written or oral protocol information
研究组 & 干预措施
MWA
Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment.
干预措施: MWA (Device)
SBRT
3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy.
干预措施: SBRT (Radiation)
结局指标
主要结局
Freedom from local lesion progression (analyzed on patient-level)
时间窗: 1 year
* Defined as the time from randomization to local progression * Censoring: death from any cause, last follow-up * No censoring on disease progression outside of the treated lesions * Local lesion progression is defined as \>20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions
次要结局
- Overall survival(From enrollment to 01/01/2026 - minimum follow-up 1 year after treatment for all randomised patients.)
- ≥ grade 3 toxicity potentially associated with the treatment(1 month after treatment)
- Toxicity profile as descriptive statistics(From enrollment to last follow-up 5 years after treatment)
研究者
Signe Lenora Risumlund
Senior consultant
Rigshospitalet, Denmark