Memory Preservation and Functional Brain Magnetic Resonance Imaging Changes With Conformal Avoidance of the Hippocampal Neural Stem-cell Compartment During Prophylactic Cranial Irradiation for Small Cell Lung Cancer Patients: A Prospective, Randomized Phase-II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- memory preservation
研究概览
简要总结
This is a prospective, randomized phase-II study observing the memory preservation and functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation for small cell lung cancer patients.
详细描述
Brain metastasis is rather high in small cell lung cancer patients. Prophylactic cranial irradiation(PCI) is the standardized treatment. However, cognitive dysfunction like memory damage is observed in quite a number of patients after brain irradiation, which may due to the hippocampus being irradiated. Thus, the investigators conduct the study by reducing the dose to the hippocampal neural stem-cell compartment (HAZ) during PCI.
Patient Population: Age: 18-65y; small cell lung cancer undergoing PCI; Eastern Cooperative Oncology Group (ECOG) score: 0-1.
The patients are randomized to 2 arms:
Arm Routine PCI: PTV(planning target volume) 25Gy/10F. Arm Hippocampus avoidance PCI(HA-PCI): PTV 25Gray(Gy)/10Fraction(F), HAZ Dmin<9Gy Dmax<16Gy).
Measurements: Hopkins verbal learning test(HVLT) and functional brain magnetic resonance imaging.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically conformed small cell lung cancer;
- •Complete response (CR)/partial response (PR) after chemo-radiotherapy;
- •ECOG (Eastern Cooperative Oncology Group) : 0-1;
- •No imaging evidence of brain metastasis before PCI;
- •Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
- •Able to understand this study and have signed informed consent.
排除标准
- •Unable to receive MRI;
- •Medical history of central nervous system, cognitive or psychological diseases;
- •The expectation of life is less than 6 months;
- •Female in pregnancy or lactating;
- •The researchers consider the patient not appropriate to be enrolled.
结局指标
主要结局
memory preservation
时间窗: 2 years
responses to Hopkins Verbal Learning Test
次要结局
- overall survival(2 years)
- image changes of brain(2 years)
- hippocampus metastasis(2 years)