A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 397
- 试验地点
- 4
- 主要终点
- Plan creation-Phase I
研究概览
简要总结
This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.
- The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.
- Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures
详细描述
This research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation to treat cancer.
The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.
In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.
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
- •Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.
- •Tumor size ≤ 7cm
- •Age 18 years of older.
- •ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- •Ability to understand and the willingness to sign a written informed consent document.
- •Specific eligibility requirements for each disease site with be covered in each specific cohort.
排除标准
- •Specific exclusion requirements for each disease site with be covered in each specific cohort
- •History of allergic reactions attributed to gadolinium-based IV contrast.
- •-- Note: If a patient will not receive contrast, this is not applicable
- •Pregnant women are excluded from this study.
- •Severe claustrophobia or anxiety
- •Participants who cannot undergo an MRI
结局指标
主要结局
Plan creation-Phase I
时间窗: 1 Year
Generating adaptive plans
Delivery Success Rate for SMART across multiple tumors-Phase I
时间窗: 1 year
Enrolling patients and delivering SMART on the MR Linac
Tumor visualization-Phase I
时间窗: 1 Year
Assessing tumor using MR guidance before, during and after MR-guided treatment patient
Rate of Improvement in Tumor Control-Phase II
时间窗: 1 Year
Statistical power will be defined in each cohort individually and will be specific to each disease site tested.
次要结局
- Number of Patients with Acute Toxicity-Phase I(90 Days)
- Number of Participants with long term toxicity-Phase II(365 Days)
- Overall Survival Rate-Phase II(365)
- Disease Specific Survival Rate-Phase II(365 Days)
- Duration of treatment-Phase 1(90 Days)
- Number of treatment fractions-Phase1(90 Days)
研究者
Jonathan Leeman, MD
Principal Investigator
Dana-Farber Cancer Institute