NCT00581113终止3 期
A Study of Neural Stem Cell (NSC) Preserving Whole Brain Radiation Therapy (WBRT) and Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.
研究概览
简要总结
For patients with 1-6 intraparenchymal brain metastases from various primary histologies (except for melanoma), stereotactic radiosurgery (administered upfront or concurrently) or complete surgical resection with neural stem cell (NSC)-preserving whole-brain radiotherapy (WBRT) results in improved neurocognitive profile over standard WBRT. The goal of this study is to assess feasibility of this treatment approach.
详细描述
Cancer patients (except patients with melanoma) with 1-6 brain metastases are randomized to receive standard whole brain radiation therapy or whole brain radiation therapy in a neural stem cell-preserving manner.
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
- •Histologically confirmed non-melanoma primary malignancy with 1-6 intraparenchymal brain metastases (or small cell lung cancer being considered for prophylactic brain irradiation (PBI) with no demonstrable intracranial lesions).
- •A diagnostic contrast-enhanced magnetic resonance imaging (MRI) demonstrating the presence of 1-6 brain metastases performed within 4 weeks of registration. Note: If small cell lung cancer primary and patient being considered for PBI, MRI must demonstrate no intracranial lesions.
- •Patients with totally resected intraparenchymal brain metastases; not all lesions need be resected if all other criteria are satisfied (no more than 6 total lesions)
- •The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have maximum diameter of no more than 4 cm in any dimension on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter.
- •Metastatic lesions must be distributed peripherally, that is, at least 0.5 cm lateral (outside) of the lateral ventricles and/or hippocampus bilaterally. Posterior fossa metastatic lesions are allowed in the study.
- •Age 18 years or older.
- •Zubrod performance score 0-
- •Neurologic function score 0, 1, or
- •Patients receiving glucocorticoids should be tapered to the lowest possible dose, or altogether, as judged by the participating physician. If glucocorticoid dose is adjusted or given for the first time, patient must remain on stable dose of glucocorticoids for at least 3 days prior to initial Neurocognitive Assessment Protocol (NAP), CT and MR imaging.
排除标准
- •Major medical illnesses or psychiatric impairments, which in the investigators opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
- •For patients who have undergone subtotal resection, residual disease must be 4 cm in maximum diameter.
- •Inability to obtain histologic proof of primary malignancy.
- •Patients with leptomeningial metastases documented by MRI or cerebral spinal fluid (CSF) evaluation.
结局指标
主要结局
Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.
时间窗: 12 months post RT
Brain metastases bi-dimensional area
次要结局
- Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.(12 months after end of radiation therapy)
研究者
研究点 (2)
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