A Prospective Study on Online Adaptive Radiotherapy (ART) Using the ETHOS Linear Accelerator for Various Tumor Entities and the Feasibility of Integrating Multi-Parametric Patient Data Into the Adaptive Workflow
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 649
- 试验地点
- 1
- 主要终点
- Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities
研究概览
简要总结
The study focuses on the scientific and clinical evaluation of online adaptive radiotherapy (ART) using the Varian/SHS ETHOS treatment system. In this study, radiation treatment plans are dynamically adjusted on a daily basis over several weeks of therapy to account for anatomical shifts in either the tumour or adjacent normal tissue - a capability that has been difficult to achieve due to technical limitations. With the ETHOS accelerator, such real-time adjustments can be made based on cone beam computed tomography (CBCT). This is a prospective observational study with the primary objective of investigating the feasibility and acceptability of performing ART with ETHOS for different tumour entities. The study will also evaluate the feasibility of integrating multi-parametric data sets into the ART workflow, such as standardised electronic feedback on treatment toxicity from both patients (ePROMS) and physicians (ePRT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (>18 years)
- •All tumor entities with an indication for radiotherapy and/or chemoradiotherapy
- •Signed informed consent
排除标准
- •Pregnancy
- •Patients who are not capable of giving consent
结局指标
主要结局
Number of Successfully Completed Adaptive Radiotherapy Sessions in Patients with Various Tumor Entities
时间窗: Throughout the treatment period, up to 6 weeks.
This measure evaluates the success rate of adaptive radiotherapy sessions with ETHOS across different tumor types. It measures the total count of adaptive treatment sessions that were completed without interruption or complication for each patient.
次要结局
- Impact of Adaptive Radiotherapy on Patient Quality of Life Assessed by EORTC QLQ-C30(2 years)
- Local Control(2 years)
- Fatigue Levels in Patients Undergoing Adaptive Radiotherapy Assessed by FACIT-F(2 years)
- Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Organs at Risk in Patients with Various Tumor Entities(Throughout the treatment period, up to 6 weeks.)
- Number of Adaptive Radiotherapy Sessions with Dosimetric Benefits to Target Coverage in Patients with Various Tumor Entities(Throughout the treatment period, up to 6 weeks.)
- Number of Adaptive Radiotherapy Sessions with Dosimetric Benefit to Organs at Risk Following ePROMs and ePRT-based Plan Adjustments in Patients with Various Tumor Entities(Throughout the treatment period, up to 6 weeks.)
- Patient Reported Toxicity(2 years)
- Physician Reproted Toxicity(2 years)
研究者
Goda Kalinauskaite
Principal Investigator
Charite University, Berlin, Germany