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
- 1
- 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.
研究组 & 干预措施
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 7 Gy x 5 fractions
干预措施: 8 Gy (Radiation)
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 7 Gy x 5 fractions
干预措施: 9 Gy (Radiation)
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 7 Gy x 5 fractions
干预措施: 7 Gy (Radiation)
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 6 Gy x 5 fractions.
干预措施: 6 Gy (Radiation)
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 6 Gy x 5 fractions.
干预措施: 7 Gy (Radiation)
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 6 Gy x 5 fractions.
干预措施: 8 Gy (Radiation)
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