Impact of Reducing the Irradiation Volume on Survival, Toxicity, and Quality of Life in Patients With Glioblastoma Treated With Radiochemotherapy: a Prospective Multicenter Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 347
- 试验地点
- 46
- 主要终点
- Overall Survival
研究概览
简要总结
The objective of the BELGICA trial is to evaluate if radiotherapy could be given in a more focused manner in patients with glioblastoma in order to reduce side effects and improve quality of life.
The glioblastoma (GBM) is the most common and aggressive tumour originating from the brain, affecting approximately 600 patients per year in Belgium. The treatment consists in surgical resection of the tumour (when feasible), followed by a combination of radiotherapy and chemotherapy. Despite multimodal treatment (surgery, radiotherapy, and chemotherapy), the life expectancy of patients with GBM remains limited, with an average survival of 12-18 months and only 5% of patients surviving more than 5 years. In addition to limited survival, most patients with GBM experience impaired quality of life, both because of the disease and treatments.
Radiotherapy is a treatment where radiation is used to kill cancer cells. In GBM, radiotherapy is targeted at the tumour (or tumour bed if the tumour was resected) with a safety margin around it (the "Clinical Target Volume" or CTV) to account for potential microscopic spread of the tumour. The downside of this safety margin is that a substantial amount of brain tissue is irradiated, which can lead to treatment toxicity. Reducing the CTV margin would enable to decrease the volume of brain being irradiated and could thereby allow to reduce the side effects of brain irradiation.
The BELGICA trial (Achieving a BEtter outcome through Limiting the GlIoblastoma Clinical tArget volume) is a national multicentre trial which will evaluate if reducing the irradiation volume in glioblastoma is safe and allows for lowering side effects and improving quality of life.
详细描述
INDICATION :
Patients with newly diagnosed glioblastoma for whom radiochemotherapy is indicated
RATIONALE :
Glioblastoma is the most frequent primary malignant brain tumour, annually affecting approximately 600 patients in Belgium.
The current management of glioblastoma includes surgical resection (when feasible), followed by radiotherapy (RT) and chemotherapy. Despite this multimodal treatment, the prognosis of patients with glioblastoma is dismal with a median overall survival of approximately 1 year.
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
- 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
- •Participants capable of giving informed consent
- •Age >= 18 y.o.
- •WHO performance status 0-2
- •Newly diagnosed glioblastoma (Histologically proven glioblastoma per WHO 2021 classification based on biopsy or resection )
- •Indication of chemoradiotherapy confirmed by multidisciplinary tumour board
排除标准
- •Participation in a competing trial
- •Known contraindication to undergo MRI scans
研究组 & 干预措施
Standard of Care
干预措施: Radiotherapy (CTV=15mm) (Radiation)
Interventional arm
干预措施: Radiotherapy (CTV=10mm) (Radiation)
结局指标
主要结局
Overall Survival
时间窗: From randomization to the end of the study
Number of days from date of randomization to the date of death due to any cause
次要结局
- Neurocognitive functioning(at baseline, 1 month after radiotherapy and at 1 year)
- Health-related Quality of Life(From enrollment until end of follow-up (2 years))
- Progression-free survival(From randomization until end of follow-up (2 years))
- Pattern of recurrence(From randomization until end of follow-up (2 years))
- Anti-edema therapy(From randomization until end of follow-up (2 years))
- Radiation-induced toxicity(From enrollment until end of follow-up (2 years))