Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)
研究概览
简要总结
The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients.
In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.
详细描述
Prophylactic cranial irradiation (PCI) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (SCLC) who have shown benefit after chemotherapy with or without thoracic radiotherapy.
Because hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of PCI should result in lower rates of memory loss.
Previous studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (IMRT) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives.
The main objective of this trial is compare neurocognitive functioning following hippocampal avoidance PCI to standard PCI treatment measured by Free and Cued Selective Reminding Test (FCSRT). The FCSRT measures verbal learning and memory. The FCSRT emphasizes encoding specificity during learning and recall. One of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (MRI). Others objectives are to evaluate quality of life (QoL) and the rate of metastases in the hippocampus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •New diagnosed cytological or histologically confirmed Small cell lung carcinoma (stage I-IV) candidate for PCI, for example, without progressive disease after chemo-radiotherapy in stage I-III or after response after chemotherapy in stage IV
- •Performance status ≤ 1
- •Negative MRI of the brain within one month before protocol entry
- •Patient must give written informed consent before registration
排除标准
- •Prior radiotherapy to the brain
- •History of brain metastases
- •Pregnancy or lactation
结局指标
主要结局
Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)
时间窗: Change from baseline to 3 months
Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation
次要结局
- Hippocampus volume (brain magnetic resonance imaging) (MRI)(Change from baseline to 3, 6,12 and 24 months)
- Adverse effects (according to Common Toxicity Criteria for Adverse Effects)(Change from baseline to 3, 6,12 and 24 months)
- Overall survival(Up to 5 years)
- Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)(Change from baseline to 6,12 and 24 months)
- Quality of life (measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)(Change from baseline to 3, 6,12 and 24 months)
- Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)(Change from baseline to 3, 6,12 and 24 months)
研究者
Nuria Rodriguez de Dios
Principal Investigator
Grupo de Investigación Clínica en Oncología Radioterapia
