Study Phase I Dose Escalation With Hypofractionated Stereotactic Radiotherapy in Patients With 1-3 Unresectable Brain Metastases
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Maximum Tolerance Dose
研究概览
简要总结
Brain metastases occur in 20-40% of patients with metastatic cancer. The standard treatment is based on whole brain radiation therapy and local treatment of metastases as neurosurgery or radiosurgery. However, many cases can not receive a standard local treatment, and local relapse occurs in almost 50% of cases treated with only whole brain irradiation. There are retrospective studies of increased radiation dose at the site of metastasis with hypofractionated stereotactic radiotherapy (HSRT) with favorable results, but there are no controlled studies regarding the safety of radiation dose in these situations. This study is a phase I study to evaluate the maximum tolerance dose (MTD) with HSRT as a way to increase the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for surgery or RS.
详细描述
RADIOTHERAPY WBRT Patient in supine position Immobilization of the head with a thermoplastic mask Simulation with computed tomography (CT) with contrast.
Design:
Clinical target volume (CTV): brain and meninges to the foramen magnum Planned treatment volume (PTV): 5 mm from the CTV in all directions
- Planning:
- Technique: Two latero-lateral fields, with permission to use field inside the fields, known as "field-in-field".
- Isodose prescription: 95% of the dose covering 95% of PTV
- Maximum dose allowed in the PTV: 15% higher than the prescribed dose
- Dose / fractionation: 30 Gy in 10 fractions of 3 Gy once a day, five times a week
- Treatment Equipment: Linear accelerator of 6-MeV photons (Varian Clinac 600 CD, Varian Medical Systems, Palo Alto, CA, USA)
HSRT Planning HSRT
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 1-3 brain metastases with histological diagnosis of malignancy and ineligible for surgery or RS
- •Age ≥18 years
- •Karnofsky Performance Status (KPS) ≥ 70%
- •"Status" of neurological function: zero to 3
- •Anticipated survival > 3 months
- •Informed consent for this research signed
排除标准
- •Prior brain irradiation for any reason
- •Indian race
- •Primary tumor of lymphoma, leukemia, germ cell, small cell carcinoma or central nervous system
- •Leptomeningeal dissemination
- •single or multiple metastases with surgical (patients with KPS ≥ 70, with metastatic site in an area not eloquent or herniation causing mass effect or hydrocephalus) or RS indication(patients with KPS ≥ 70 and metastatic lesion <4 cm in diameter with distance to chiasm, tract and optic nerves, and brain stem > 5 mm)
- •Inability to have MRI
- •Patients who have undergone prior treatment for specific brain metastases (eg surgery, RS, chemotherapy), excluding corticosteroids
- •People with mental incapacity
- •People in a relationship of dependence as prisoners, soldiers, students, staff, etc..
结局指标
主要结局
Maximum Tolerance Dose
时间窗: Always after 3 patients recruited (up to 30 days after completion of radiotherapy planned)
To establish the MTD with HSRT as a way to increase the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for surgery or RS, and find the dose for phase II study.
次要结局
- Neurocognitive benefit(Baseline and up to 30 days after completion of radiotherapy planned)
- Radiotoxicity(Up to 30 days after the end of radiotherapy)