Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire
研究概览
简要总结
The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.
详细描述
The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient with newly diagnosed brain metastases
- •Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
- •At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
- •Number of brain metastases lower or equal to 5
- •Indication of radiosurgery treatment
- •Age ≥ 18 years old
- •ECOG-PS 0-2
- •Expected survival > 3 months
- •Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment.
- •A non-opposition form must have been completed by the patient
排除标准
- •Previous cancer (< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
- •Previous brain radiotherapy
- •Neurological pathology with cognitive disorders existing before the study
- •Having a contraindication for MRI
- •Associated leptomeningeal disease
- •Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease)
- •Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months
- •Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons
研究组 & 干预措施
questionnaire administration
Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)
干预措施: questionnaire administration (Other)
结局指标
主要结局
Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire
时间窗: 6 months
The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness
次要结局
- Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment(1 year)
- Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment(1 year)
- Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival(1 year)
- Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment(1 year)
- Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment(1 year)
- Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months(1 year)