跳至主要内容
临床试验/NCT03209128
NCT03209128终止不适用

Savings of Hippocampus and Amygdala by Archetherapy in Cerebral Prophylactic Irradiation in Patients With Limited and / or Extended, Responsive or Stable Small Cell Lung Cancer (SCLC)

Centre Francois Baclesse, Luxembourg1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
11
试验地点
1
主要终点
Cognitive function

研究概览

简要总结

Hippocampus and amygdala are parts of the brain involved in the recognition of emotions, memories, memory, language ... It is therefore very important to protect them during irradiation of the brain.

The aim of this study is to evaluate cerebral irradiation with saving hippocampus and amygdala protects these brain functions in patients with small cell lung cancer (SCLC) Radiotherapy of the brain

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years of age
  • Patients with a limited SCLC demonstrated histologically responsive or stable to radiochemotherapy or patients with a histologically proven extended SCLC responding to chemotherapy.
  • WHO Performance Index 0-1 and / or Karnovsky Index> 70
  • Possibility of long-term monitoring

排除标准

  • Concomitant chemotherapy
  • Impossibility of performing an MRI or CT without injection
  • Presence of cerebral metastases
  • History of cerebral irradiation at any time
  • Patient suffering from severe collagenosis
  • Patient with cognitive disorders with MMSE score <24

结局指标

主要结局

Cognitive function

时间窗: until 18 months after inclusion of patient

Evaluate the cognitive function with Wechsler Memory Scale IV (WMS-IV) test

次要结局

  • Appearance of brain metastases and their location(until 18 months after inclusion of patient)
  • Secondary effects according the CTCAE v.4 criteria(until 18 months after inclusion of patient)
  • Quality of life (QOL) of patients(until 18 months after inclusion of patient)

研究者

发起方
Centre Francois Baclesse, Luxembourg
申办方类型
Other
责任方
Sponsor

研究点 (1)

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