Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of providing online, adaptive MRI-guided and gated SBRT as measured by the ability to deliver a full course of MRI-guided SBRT in at least 80% of eligible patients who have completed simulation and planning
研究概览
简要总结
The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated Co-60 MRI treatment machine. To best assess this technology, the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes. The prescription dose will be determined based on hard normal tissue constraints, and capped at 10Gy per fraction. Although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization.
- •Deemed medically fit for stereotactic body radiation therapy by the treating physician.
- •At least 18 years old.
- •Karnofsky Performance Status ≥ 70
- •Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
- •Able to understand and be willing to sign an IRB approved written informed consent document (or legally authorized representative, if applicable).
排除标准
- •Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT
- •Current central nervous systemic disease.
- •Widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease).
- •Actively receiving any investigational agents.
- •Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- •Medical contraindication to undergoing MR imaging.
研究组 & 干预措施
Arm 1: MRI-guided SBRT
- Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
- Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV.
- All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
干预措施: MRI-guided SBRT (Device)
Arm 1: MRI-guided SBRT
- Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
- Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV.
- All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
干预措施: EORTC QLQ-C30 Questionnaire (Behavioral)
Arm 1: MRI-guided SBRT
- Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
- Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV.
- All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
干预措施: EORTC QLQ-OV28 Questionnaire (Behavioral)
结局指标
主要结局
Feasibility of providing online, adaptive MRI-guided and gated SBRT as measured by the ability to deliver a full course of MRI-guided SBRT in at least 80% of eligible patients who have completed simulation and planning
时间窗: Completion of all enrolled patients (up to 2 years)
次要结局
- Safety as measured by acute toxicities(Up to 90 days post completion of treatment)
- Safety as measured by late toxicities(91 days to 6 months post completion of treatment)
- Response rate(3 months post treatment)
- In-field control rate(6 months post treatment)
- Local control rate(3 months post treatment)
- Regional control rate(3 months post treatment)
- Distant control rate(3 months post treatment)
- Progression-free survival (PFS) rate(6 months post treatment)
- Disease-free survival (DFS) rate(6 months post treatment)
- Overall survival (OS) rate(6 months post treatment)
- Patient-reported health-related quality of life (HRQOL)(6 months post treatment)
- CA-125 response levels(6 months post treatment)