Re-irradiation of High Grade Gliomas: a Quality of Life Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change from baseline in the palliative effect of re-irradiation in patients with a high grade glioma, defined by quality-of-life parameters
研究概览
简要总结
Patients with a high grade glioma have an increasing overall survival and progression free survival after initial treatment. Because of a better performance status these patients are more often eligible for re-treatment with for example radiotherapy. However, to date only a few prospective studies on re-irradiation of gliomas exist and very little is known about the effects of re-irradiation on quality of life and cognition. This trial is designed to longitudinally establish the effects of re-irradiation on quality of life, cognition and physical performance in patients with a high grade glioma. Based on the currently available information the investigators hypothesize that quality of life after re-irradiation can be kept stable until further tumour progression.
详细描述
Current treatment regimes, with the addition of temozolomide, have improved progression-free survival as well as overall survival for patients with a high grade glioma. The median overall survival (MOS) for patients with a glioblastoma (GBM) is 14.6 months, with a progression free survival (PFS) of 6.9 months.
Due to longer survival and a better performance status, patients often reach a point at which re-treatment is feasible. Treatment options for recurrent glioblastoma and anaplastic glioma can include surgery, chemotherapy and re-irradiation. Re-irradiation of patients with recurrent high grade glioma is slowly becoming standard of care. It provides a comparable overall survival to palliative chemotherapy. In case of GBM there is a median time to progression after treatment of 20-27 weeks and a MOS of 26 to 60 weeks.
Patients with tumor recurrence have a significantly worse quality of life compared to patients without recurrence at the same follow-up. They experience significantly more problems with physical functioning (e.g. motor dysfunction, weakness of legs, visual disorders), work or other daily activities, mental health (e.g. future uncertainty) and general health.
With regard to re-irradiation, current available data is mostly provided by retrospective studies which often lack solid quality of life data. Endpoints include e.g. performance status, clinical (neurological) status and decreased steroid requirement after treatment. These endpoints are however inadequate to determine quality of life accurately.
Several studies have used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) and the brain cancer module (QLQ-BN20) scales to assess quality of life. The latter consists of 20 items including visual disorder, motor dysfunction, various disease symptoms, treatment toxicity and future uncertainty. A change of 10 points or more on these scales can be considered clinically relevant.
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
- 否
入选标准
- •Histologically proven high-grade glioma anaplastic astrocytoma or glioblastoma
- •Age ≥ 18 years
- •WHO performance status ≤ 2
- •Scheduled for re-irradiation of a high grade glioma
- •The patient is willing and capable to comply with study procedure
排除标准
- •Life expectancy < 3 months
结局指标
主要结局
Change from baseline in the palliative effect of re-irradiation in patients with a high grade glioma, defined by quality-of-life parameters
时间窗: baseline, 6-8weeks, 12 weeks, 18-20 weeks, 30-32 weeks
These Quality of life parameters include: * The change in the EORTC QLQ-C30 score from baseline to endpoint * The change in the EORTC QLQ-BN20 score from baseline to endpoint * The change in the EORTC QLQ-FA13 score from baseline to endpoint * The change in cognition from baseline to endpoint as measured by the HVLT-R, the TMT, the Stroop-test and the COWA * The change in grip strength from baseline to endpoint
次要结局
- Overall survival of patients with glioblastoma and anaplastic glioma after re-irradiation(6 months after the last patient is included)
- Progression free survival of patients with glioblastoma and anaplastic glioma after re-irradiation(6 months after the last patient is included)