A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants
研究概览
简要总结
This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.
详细描述
The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques.
In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern.
In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.
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
- •Age > 18
- •Histologically or cytologically confirmed invasive cancer
- •Bulky tumor > 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
- •Treated indicated for palliative intent
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •Anticipated treatment deemed safe on pre-review by PI
- •For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID
- •Willing and able to provide informed consent
- •Discussion with medical oncology or surgical specialty
排除标准
- •Age < 18
- •ECOG performance status 3-4
- •Planned for definitive, curative management
- •For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
- •Tumor encasing critical structure, as defined by the treating MD.
研究组 & 干预措施
Pro-GRID treatment Arm
Patients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction.
干预措施: Pro-GRID (Radiation)
结局指标
主要结局
Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants
时间窗: 1.5 years
To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.
次要结局
- Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy(1, 6 and 12 months post-treatment)
- Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy(1, 6 and 12 months post-treatment)
- Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)(3 months post-treatment)