A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Local Disease Control Rates
研究概览
简要总结
30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.
详细描述
Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung.
- •Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc).
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- •Age ≥18 years
- •ECOG performance status >/= 2 (Karnofsky≥60%)).
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with more than >/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest.
- •Patients who are receiving any other investigational agents.
- •Patients with active systemic, pulmonary, or pericardial infection.
- •Pregnant or lactating women
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Uncontrolled inter-current 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.
- •Chemotherapy concurrent with SBRT is not allowed
研究组 & 干预措施
Single Fraction of SBRT
Stereotactic Body Radiation Therapy delivered in a single session on one day
干预措施: Stereotactic Body Radiation Therapy (Radiation)
Fractionated SBRT
Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Local Disease Control Rates
时间窗: 6 MONTHS
Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1
次要结局
未报告次要终点
研究者
Ronald McGarry
Principal Investigator
University of Kentucky