Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Steroid dosage required to control brain edema on the last day of radiotherapy in each arm
研究概览
简要总结
To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.
详细描述
Multicentre, randomized (1:1), double blinded trial:- Arm A: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan 50mg*2/day until the halting for any reason - Arm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason.
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
- Double (Participant, Investigator)
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
- •18 years or older
- •Histologically confirmed glioblastoma (Grade 4 WHO)
- •patients eligible for radiotherapy and concomitant Temozolomide
- •KPS ≥ 50%
- •Adequate hematologic, liver and renal functions
排除标准
- •Patients unable to undergo an MRI with contrast
- •Patients without any residual tumor left on the screening MRI of both flair and contrast-enhanced lesions complete surgical resection)
- •Any prior treatment of glioblastoma including any local therapy (immunotherapy, Gliadel wafers, .....) during or after surgical resection
- •Any on-going treatment for high blood pressure at time of inclusion, whatever the therapeutic class of drugs
- •Systolic blood pressure <110 mmHg.
- •relative or definite contra-indication to Losartan:
- •Pregnant or breast feeding women; Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception
- •Non-affiliation to the "sécurité sociale"
研究组 & 干预措施
Arm A: Losartan
Arm A: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan 50mg*2/day until the halting for any reason
干预措施: Losartan (Drug)
Arm B: Placebo
Arm B: Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
干预措施: Placebo (Drug)
结局指标
主要结局
Steroid dosage required to control brain edema on the last day of radiotherapy in each arm
时间窗: Up to Day 42+ 1 month
次要结局
- side-effects of steroids(up to day42 +1 month)
- Quality of life (EORTC)(Day-10 at -7, Day 42, Day 42+1 month)
- Overall survival(up to 24 months)
- Progression free survival(up to 24 months)
- Tolerance (NCI-CTCAE v3.0)(up to day42 +1 month + 7 days)
- HbA1C(Day -10 at -7, D42, Day 42+1month)
- Survival(at 1 year, 2 year)
- Steroids dosage 1 month after the end of RT(Day 42+ 1 month)
- Assessment of cerebral edema on MRI(Day -28 at -13, Day 42, Day 42+1 month)
- Blood pressure(Day -10 at -7, Day0, 42, Day 42+1month)
- glycemia(Day -10 at -7, Day14, 28, 42, Day 42+1month)
- body weight(Day -10 at -7, Day42, Day 42+1month)
- Executive functions ( " Moca test ")(Day-10 at -7, Day 42, Day 42+1 month)
- Performance status (KPS) at the end, 1 month , and 2 months after the end of RT(at the end, 1 month, and 2 months after the end of RT)