Daily Adjustment of the Radiation Dose in MRI-guided Stereotactic Radiotherapy for Tumors in the Abdominal and Pelvic Regions (ACTION)
Adaptive Fractionation in Online MR-guided SBRT for Abdominal and Pelvic Target Volumes
SBRT delivers high-dose radiation to precisely defined target volumes and is an effective locally ablative treatment option for both primary tumours and oligometastases in various settings, including lesions in the abdomen or pelvis. However, SBRT in these regions faces considerable challenges such as inter-fractional organ motion and anatomical deformation, which can compromise treatment precision.
MR-guided SBRT offers a solution, providing superior soft-tissue contrast and enabling real-time, online treatment plan adaptation over the course of SBRT. This approach reduces the risk of geographical miss and overdose to adjacent, vulnerable OARs. Currently, MR-guided SBRT uses a fixed dose per fraction, only adjusting target volume and OAR contours for anatomical changes when performing plan adaptation. However, overlaps between planning target volumes (PTVs) and dose-limiting OARs regularly require compromises in PTV coverage. To address this, AF aims to also adjust dose per fraction based on daily PTV-OAR overlap. With this approach, more dose is applied on treatment days with less PTV-OAR overlap while less dose is applied on days with more PTV-OAR overlap. This trial assesses the feasibility of AF in MR-guided SBRT for abdominal and pelvic tumours that show PTV-overlap with one or more dose-limiting OARs, ultimately aiming to enhance PTV dose coverage without increasing toxicity.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jan Unkelbach, Prof. Dr. rer. nat.
- 电话号码：+41 44 255 85 49
- 邮箱：jan.unkelbach@usz.ch
研究联系人备份
- 姓名：Lena Kretzschmar, Dr. med.
- 邮箱：lena.kretzschmar@usz.ch
学习地点
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Canton of Zurich
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Zurich、Canton of Zurich、瑞士、8091
- 招聘中
- University Hospital Zurich
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Karnofsky performance status ≥70
- Abdominal or pelvic malignancy (primary or secondary) with previous histological confirmation of the primary tumour, amenable to SBRT in 5 fractions (excluding SBRT to primary tumour in patients with prostate cancer) Note: patients with primary prostate cancer are eligible, but SBRT to the primary tumour in the prostate cannot be performed within the study
- Total prescribed SBRT dose > 30 Gy (constraint for dose-limiting OAR) over 5 treatment fractions
- Distance of the GTV ≤ 1 cm from at least one dose-limiting OAR (bowel / duodenum / stomach) in the available diagnostic images
- Patients able to tolerate long (approximately 60 minutes) treatment time according to clinical evaluation of the treating radiation oncologist
- Patients willing and able to comply with scheduled visits, treatment, and other trial procedures
Exclusion Criteria:
- Previous radiation therapy directly overlapping with planned SBRT (type I re-irradiation)
- More than one PTV irradiated in the same plan
- Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia
- SBRT not indicated or not possible
- Inability to follow the procedures of the trial, e.g. due to language problems of the participant
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：RT with AF
Patients with PTV/OAR overlap will receive AF, with dose adapted daily based on anatomy.
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The fraction dose to the PTV will be adapted based on the volume overlap of PTV and the dose-limiting OAR(s) (bowel / duodenum / stomach) on the planning MRI scan of the day ("geometry-of-the-day").
The treatment plan is then approved by the treating physician and independently verified according to department-internal standard.
MR-guided fraction dose adaptation will be repeated at each of the 5 fractions, until the prescribed total dose is reached.
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有源比较器：RT without AF
Patients without PTV/OAR overlap will receive standard fractionated treatment.
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Patients that qualify for inclusion in the study but for whom AF is no viable treatment due to lacking PTV/OAR overlap in the planning scans.
These patients are treated according to clinical standard of care (SoC), i.e. without dose adaptation, and function as a control group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Proportion of patients with successful daily dose adaptation
大体时间：from enrollment to end of treatment at 1-2 weeks
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Proportion of patients treated with daily dose-adapted treatment, who received at least one fraction of non-uniformly fractionated treatment with expectation of a benefit in PTV-coverage of ≥ 1ccGy
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from enrollment to end of treatment at 1-2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Acute treatment toxicities
大体时间：during treatment (1-2 weeks) and until 90 days after
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Acute treatment toxicities for all included patients measured with Common Terminology Criteria for Adverse Events
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during treatment (1-2 weeks) and until 90 days after
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Interfractional variation in PTV/OAR overlap volume
大体时间：during treatment (1-2 weeks)
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interfractional variation in PTV/OAR overlap volume, in cc
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during treatment (1-2 weeks)
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Interfractional variation in GTV/OAR distance
大体时间：during treatment (1-2 weeks)
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interfractional variation in GTV/OAR distance, in mm
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during treatment (1-2 weeks)
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Dosimetric difference in PTV-coverage between algorithm-based calculation and the reference plan
大体时间：after end of treatment (2 weeks after last fraction)
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PTV coverage quantified as the area above the dose-volume-histogram curve measured in cc x Gy
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after end of treatment (2 weeks after last fraction)
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合作者和调查者
调查人员
- 首席研究员：Reinhardt Krcek, Dr. med.、University of Zurich
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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