Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Percent difference between initial reference plan and adaptive weekly RT plan
研究概览
简要总结
The purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator [Linac]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery.
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
- 否
入选标准
- •Pathologically confirmed new diagnosis of HPV-positive OPC [i.e. Base of tongue, tonsil, soft palate, vallecula, and posterior pharyngeal wall]
- •American Joint Committee on Cancer (AJCC) 8th edition Stage I-III planned for definitive chemoradiation.
- •Members of all races and ethnic backgrounds
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for duration of study participation.
- •Must be able to understand and sign an Institutional Review Board (IRB)-approved written informed consent document.
排除标准
- •Prior surgery, chemotherapy, or radiation treatment for head and neck cancer
- •Prior history of cancer other than non-melanomatous skin cancer
- •Distant metastases (cM1) or (pM1) disease)
- •Evidence of a compromised airway
- •Medical contraindications to MRIs
- •Unable to tolerate MRIs without sedation
- •Pregnant patients
- •Breastfeeding patients
- •Eastern Cooperative Oncology Group (ECOG) performance status >1
结局指标
主要结局
Percent difference between initial reference plan and adaptive weekly RT plan
时间窗: Up to 6 months
Weekly adaptive plans will be compared to the initial reference plan and compared using a percent difference equation estimating the actual values of the quantities used as dosimetric constraints for each participant between the initial reference plan and the weekly adaptive plan\[s\].
Evaluation of deformable imaging registration
时间窗: Up to 6 months
For evaluation of deformable imaging registration, deformed contours will be compared to the physician-segmented contours using the Dice similarity coefficient (DSC).
次要结局
- Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43(Up to 1 year)
- Treatment times recorded in minutes(Up to 6 months)
- Patient-reported Quality of Life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30)(Up to 1 year)
研究者
Stuart Samuels
Associate Professor of Clinical Medicine
University of Miami