A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 204
- 试验地点
- 6
- 主要终点
- Change in swallowing score
研究概览
简要总结
The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.
详细描述
This is a randomized phase III trial to evaluate the effectiveness of MLAP compared to Standard of Care. Patients will undergo a randomization procedure with a variable allocation ratio where the first third of patients are randomized 3:1 in favor of SOC, the next third randomized 1:1, and the last third randomized 1:3 in favor of MLAP. This is done to give dosimetrists time to optimize the MLAP workflow. Since the treatment team may learn to improve their treatment planning process in the SOC arm through interactions with RapidPlan, as a sensitivity analysis, the primary and secondary goals will be re-analyzed including time of registration as a moderator of the treatment effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Age ≥ 18 years at time of registration
- •Receiving curative intent intensity modulated radiotherapy for head and neck primary cancer at the discretion of the treating medical doctor (MD)
- •Provide written informed consent or allow legally authorized representative to consent on behalf of a participant
- •Willing to return to enrolling institution for study follow-up visit
排除标准
- •Incarcerated
- •Unable to provide informed consent
- •Prior Head and Neck (H&N) radiation therapy
- •Planned radiation dosing LK<30 Gy or >76 Gy
研究组 & 干预措施
Arm A: Standard of care (SOC) treatment planning
Patients randomized to the SOC treatment planning arm will receive a treatment planning computed tomography (CT) scan followed by dosimetric planning with a medical dosimetrist; and the plan will be reviewed by a medical physicist and radiation oncologist. This is the current standard practice for all radiation oncology patients.
干预措施: Radiation Therapy Standard of Care (SOC) (Radiation)
Arm B: Machine Learning Assisted Planning (MLAP)
Patients randomized to the MLAP arm will receive a treatment planning scan followed by MLAP through the RapidPlan module produced by Varian. Of note, RapidPlan is an FDA cleared module with treatment planning being the approved usage for the program. The RapidPlan module has site specific treatment packages for different disease sites. These separate disease specific packages have different capabilities. For example, the Head and Neck package currently audits dosimetrist-generated plans for possible improvements. The MLAP arm of the trial will leverage the RapidPlan module's full capabilities upwards to the FDA-approved usage.
干预措施: Machine Learning Assisted Radiation (MLAP) RapidPlan (Radiation)
结局指标
主要结局
Change in swallowing score
时间窗: Baseline (up to 30 days prior to treatment planning); up to 6 months
Will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H\&N35). The EORTC QLQ-H\&N35 is a 35-item questionnaire used to assess symptoms encountered specifically by patients with head and neck cancer. The H\&N35 consists of 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (e.g., Opening mouth, Sticky saliva, Dry mouth, etc.). Scores are combined into an overall score ranging from 0=Best to 100=Worst. Swallowing score will be measured at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+ 14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy).
次要结局
- Change in physician-reported toxicities(Baseline; up to 6 months)
- Difference in treatment plan quality metrics (PQMs) across treatment arms(Baseline; up to 6 months)
- Difference in time to complete treatment planning(Baseline; up to 6 months)
研究者
Daniel J. Ma, M.D.
Principal Investigator
Mayo Clinic