Magnetic Resonance Imaging-Guided Radiotherapy for Head & Neck SBRT on the 1.5T MR-Linac
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes.
研究概览
简要总结
This study will evaluate the feasibility and safety of using MR-guided adaptive Head and Neck stereotactic radiotherapy (SBRT) at each fraction on the 1.5T MR-Linac.
详细描述
At the Sunnybrook Odette Cancer Centre (OCC), stereotactic body radiation therapy (SBRT) (35- 50 Gy in 5 fractions delivered 2x/week) has been employed in a subgroup of palliative Head and Neck cancer (HNC) patients, as part of an institutional protocol, when greater tumor response is desirable when compared to more palliative regimens.
The MR-Linac has been approved by Health Canada for radiation treatment. With superior soft tissue contrast and the possibility for daily plan adaptation, it allows for higher treatment precision delivery, improved target coverage and greater normal tissue sparing.
As a first step, this study will evaluate the feasibility and safety of using the 1.5T MR-Linac on patients with HNC who are treated with SBRT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years and older
- •Karnofsky performance status score of ≥70
- •Biopsy-proven oligometastatic cancer to the HN
- •Biopsy-proven primary HN cancer (either mucosal, nodal, skin)
- •Patients deemed unsuitable by the treating radiation oncologist for radiation treatment with curative intent owing to advanced age, significant comorbidities, poor performance status, distant metastatic disease.
- •≥ 1 site amenable to HN SBRT
- •Capable of providing informed consent
- •Required to complete any systemic therapy ≥ 10 days prior to planned start of HN SBRT, with no plans to initiate systemic therapy ≥10 days following completion of HN SBRT.
排除标准
- •History of radiation within the projected treatment field
- •Contraindications to MR imaging per institutional policy
- •Patients with connective tissue disorders
- •History of severe claustrophobia
- •Pregnant and or breastfeeding females
- •Having an estimated glomerular filtration rate (GFR) <40 ml/min/1.73m2
结局指标
主要结局
Proportion of patients who complete ≥80% of treatment fractions in ≤60 minutes.
时间窗: 2 years
Clinical feasibility of delivering radiotherapy treatment on the MR Linac within 60 minutes and the need for patients to transfer to a CT-based linear accelerator will be monitored. The radiotherapy timing sheet will be used to record the length of time for patients to have their MR guided adaptive radiotherapy for each fraction.
次要结局
- Changes in tumor apparent diffusion coefficient (ADC) maps from diffusion weighted (DWI) MRI scan at baseline and at each fraction(2 years)
- Quality of Life as measured by the MD Anderson Dysphagia Inventory (MDADI)(2 years)
- Quality of Life as measured by the Xerostomia Questionnaire (XQ)(2 years)
- Number of participants with Acute and Late Toxicity(2 years)
- Overall survival(2 years)
- Dosimetric outcomes in HN SBRT patients treated with MR-guided adaptation as compared to non-adaptive HN SBRT.(2 years)
- Quality of Life as measured by the Patient experience Questionnaire for MR-Linac(2 years)
- Quality of Life as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)(2 years)
- Locoregional control 6 months based on RECIST criteria 1.1 and assessed on MRI or CT scan imaging(6 months)
- Progression-free survival(2 years)
研究者
Dr. Irene Karam
Radiation Oncologist
Sunnybrook Health Sciences Centre