Real-time Motion Management During Prostate and Lung Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Dosemetric accuracy
研究概览
简要总结
The goal of this interventional non-inferiority trial is to assess the accuracy of different real-time motion management radiotherapy techniques. The main question the study aims to answer are:
- What are the target margins for radiotherapy with motion management that are not inferior to target margin without motion management
- What are the dosimetric and geometrical accuracy to patient for the motion management techniques.
Participants will answer QoL questionary, and the accuracy of treatment will be assessed from treatment data.
详细描述
This study will assess the feasibility of implementing real-time tracking in a clinical setting to account for the relative motion of the moving tumours localised to the prostate or lung. The capability to track the treatment target's motion will ensure that the dose prescribed by the radiation oncologist is the dose delivered to the target and minimises side effects to the critical organs.
During radiation treatment, the target position will be monitored in real-time using built-in imaging technology. The radiation beam shape will be altered to compensate for the moved target positions by the treatment delivery system. The delivered dose to the patient will be calculated after the treatment and compared to the dose without real-time tracking to assess the potential benefit to treatment efficacy, recognising that the radiation dose received by tumour tissue is a very strong biomarker for response.
The estimated dose distributions will be compared to the original plan for non-inferiority using the dose reconstruction method based on the prostate motion trajectory and the logged MLC positions (beam shapes).
Also, the impact on organs at risk doses due to MLC target tracking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •For prostate cancer patients:
- •Patients histologically proven prostate adenocarcinoma
- •Prostate specific antigen (PSA) obtained within three months prior to enrollment
- •Localised prostate cancer at any stage eligible for radiotherapy: i.e. any T- or Gleason stage, but no pelvic lymph nodes can be included within the target to be treated
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Ability to understand and the willingness to sign a written informed consent document.
- •Hypofractionated radiation therapy (HYPO) fractionated patients with a prescribed dose of 42.7Gy in 7 fractions.
- •MRIOnly workflow meaning synthetic generated CT based on Magnetic resonance imaging (MRI)
- •Patients over 40 years old
- •For lung cancer patients:
- •Lung cancer or localised metastatic disease from other cancer diagnoses, accepted for stereotactic radiotherapy to 45Gy in 3 fractions
- •Lesion distinguishable on Computer Tomography and where the majority of adjacent tissue is the lung.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Is able to perform treatment simulation
排除标准
- •For prostate cancer patients:
- •Patient must have three gold fiducial markers inserted in the prostate
- •Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
- •Patients with overlapping implanted gold fiducials in X-ray imaging
- •Unfeasible to track fiducials with kv imaging/existing online imaging systems
- •For lung cancer patients:
- •Previous treatment with radiotherapy for lung cancer or lung metastasis
- •Idiopathic lung fibrosis
研究组 & 干预措施
Triggered Imaging with TrueBeam for prostate cancer
Patients will undergo radiotherapy using the Triggered Imaging technique with TrueBeam for prostate cancer. The technology on the TrueBeam allows for monitoring and gating of the radiation beam in relation to the target position.
干预措施: Triggered imaging on TrueBeam with margin reduction (Radiation)
Synchrony with Radixact for prostate cancer
Patients will undergo radiotherapy using the Synchrony technique with Radixact for prostate cancer. Multi-Leaf Collimator Adaptation (MLC) and kilovoltage (kV) Intrafraction Monitoring with the Synchrony technique on the Radixact radiotherapy machine.
干预措施: Synchrony MLC tracking on fiducials with margin reduction (Radiation)
Synchrony with Radixact for lung cancer
Patients will undergo radiotherapy using the Synchrony technique with Radixact for lung cancer. MLC Adaptation, Respiratory Motion Tracking, and kV Intrafraction Monitoring with the adaptive Synchrony technique on the Radixact radiotherapy machine.
干预措施: Synchrony MLC tracking and lung adaptive model with margin reduction (Radiation)
结局指标
主要结局
Dosemetric accuracy
时间窗: At treatment completion, approximately 1-4 weeks
Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.
次要结局
- Acute Toxicity(Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..)
- Geometric accuracy(At treatment completion, approximately 1-4 weeks)
- Motion trajectory(At treatment completion, approximately 1-4 weeks)
- Mechanical & software failure(At treatment completion, approximately 1-4 weeks)
研究者
André Änghede Haraldsson
Principal Investigator
Region Skane