LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Difference in accumulated patient dose distribution with and without KIM
研究概览
简要总结
Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.
详细描述
This is a single arm, phase II, two stage study designed to evaluate cancer targeting accuracy, treatment outcomes and treatment efficiency in 46 patients eligible for SABR for either primary or secondary liver malignancy with the incorporation of KIM.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status 0-1
- •Life expectancy >6 months
- •Number of lesions: ≤ 3
- •Lesion size : < 10 cm for a single lesion (and up to 10 cm cumulative diameter for multiple lesions)
- •Child-Pugh A or B7 within 6 weeks prior to study entry
- •Unsuitable for RFA or resection or transplant
- •Distance from GTV to luminal structures (i.e., oesophagus, stomach, duodenum, small or large bowel) ≥ 10mm
- •All blood work obtained within 6 weeks prior to study entry with adequate organ function
- •May have had previous surgery, RFA or ethanol injection
- •Patient must have been discussed at multidisciplinary tumour board with consensus opinion for SBRT
排除标准
- •HCC/cholangiocarcinoma with evidence of metastatic disease including nodal or distant metastases
- •Metastatic disease with complete liver disease response to first-line chemotherapy (i.e. no target for SBRT)
- •Previous radiation to the liver (including SIRTEX)
- •Untreated HIV or active hepatitis B/C
- •On systemic antineoplastic drug therapy within 7 days before inclusion
- •Pregnant or lactating women
研究组 & 干预措施
SABR with or without KIM
All patients will receive liver SABR. Kilovoltage Intrafraction Monitoring (KIM) tracking will be trialed during mock treatment. If KIM is successful, it will be used throughout treatment. If unsuccessful, cone beam CT will be used instead.
干预措施: Kilovoltage Intrafraction Monitoring (Device)
结局指标
主要结局
Difference in accumulated patient dose distribution with and without KIM
时间窗: 15-60 minutes (time of individual fraction delivery)
Isodose distributions and dose volume histograms for each session will be calculated with KIM corrections as treated, and estimated without KIM corrections. The planning CT scan will be used for this assessment
次要结局
- Difference in treatment time with and without KIM(15-60 minutes (time of individual fraction delivery))
- Proportion of local failures at two years for patients treated(2 years)
- Difference in PTV margins with and without KIM(15-60 minutes (time of individual fraction delivery))
- Change in dose when using KIM with and without using MLC tracking(15-60 minutes (time of individual fraction delivery)
- Difference in imaging dose with and without KIM(15-60 minutes (time of individual fraction delivery))
- Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans(15-60 minutes (time of individual fraction delivery))
- Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)(2 years)
- Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Hepatocellular Carcinoma 18 Module (EORTC QLQ-HCC18)(18 months)
- The proportion of grade 3 or higher toxicities(2 years)