A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy
研究概览
简要总结
This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.
详细描述
This study looks at dose escalation treatment in patients diagnosed with brain metastases. Treatment involve five fraction stereotactic radiotherapy for patients with brain tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter and dose escalation treatment is delivered only to the single largest tumor while all other tumors are treated with standard of care practices if they are present. A dose escalation schedule is proposed based on the monitoring of CNS toxicity and tumor size of the largest tumor, given it falls into the parameters set on diameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •All patients must have histologically confirmed malignancy.
- •All patients must have imaging suggestive of one or more brain metastases.
- •Karnofsky performance status (KPS) ≥ 60
- •Age > 18 years
- •Patients must provide written informed consent to participate in the study.
- •Patients must have less than or equal to 10 brain metastases as identified on brain MRI.
排除标准
- •History of surgical resection to the tumor of interest
- •History of radiation to the tumor of interest
- •History of previous whole brain irradiation
- •Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents.
- •Patient is unable to have MRI or MRI contrast.
- •Inability to meet the appropriate normal tissue dose constraints secondary to tumor location should result in exclusion of the patient / tumor.
- •Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.
结局指标
主要结局
Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy
时间窗: 1-2 years
To determine the maximum tolerated dose of five fraction stereotactic radiotherapy for patients with either tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter
次要结局
- Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire(1-2 years)
- Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire(1-2 years)
- Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire(1-2 years)
研究者
John Fiveash, MD
Assistant Professor - Department of Radiation Oncology
University of Alabama at Birmingham