Organ Sparing Marker-less CBCT-guided Stereotactic Adaptive Radiotherapy for Primary Non-metastasized Renal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of renal dose
研究概览
简要总结
This study aims to improve the treatment of kidney tumors using radiotherapy, by investigating whether kidney cancer can be more effectively irradiated with the help of new imaging techniques
详细描述
In total 40 patients will be treated for RCC using SBRT.
For 15 patients, additional breath-hold CBCT scans will be made during SBRT to investigate the intra- and inter-fraction uncertainty in breath-hold positions as well as assessing the feasibility of using surface guidance as a surrogate for target position.
Subsequently, 25 patients will be treated using the new motion management technique developed using the extra imaging data obtained from the first cohort of patients. It is hypothesized that either breath-hold or gating in combination with surface guidance will result in a reproducible (stable) position of the target and therefore minimal margins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 histologically proven non-metastastic RCC or high suspicion of RCC based on imaging without histological evidence
- •No metastatic lesions
- •Patients must be 18 years or older
- •Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
- •Written informed consent
排除标准
- •Previous high-dose radiotherapy in the region of the kidney
研究组 & 干预措施
Additional imaging
Additional CBCT scans will be made after each fraction, follow-up will be done using photon counting CT
干预措施: Additional radiation due to imaging (Radiation)
结局指标
主要结局
Reduction of renal dose
时间窗: At day 1 planning CTs are acquired for treatment planning. These scans will be used to make a treatment planning with standard motion management and a treatment planning will be made using novel motion management. Both plans will be compared.
The primary aim of this project is to minimize treatment margins, reducing the PTV, to optimally preserve renal function, while ensuring adequate tumor coverage as well as adhering to dose constraints of OARs. Primary endpoint of this study is the reduction of dose to the healthy ipsilateral kidney, defined as the ipsilateral renal volume receiving 50% of the prescribed dose (V50%).
次要结局
- Evaluate the current treatment, including the benefit of online adaptive radiotherapy(Day 1 planning CTs. Approximately day 14: start radiotherapy (3 times per week). At each fraction: CBCT. At completion of treatment (at approximately day 30) planning for adapted and non-adapted plans)
- Investigate treatment fraction reduction(At day 1 planning CTs are acquired for treatment planning. These will be used for treatment planning for simulated fraction schedules using standard and novel motion management)
- Change From Baseline in Tumor Contrast Enhancement on Photon-Counting CT(Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment)
- Change From Baseline in Tumor Iodine Concentration on Photon-Counting CT(Baseline (pre-treatment) and follow-up at 3, 6, and 12 months after completion of treatment)
研究者
E. (Euphemia) A.M. Froklage
Radiation Oncologist, MD PhD, principal investigator
Erasmus Medical Center