EUCTR2018-001879-20-FR进行中（未招募）1 期
Radiotherapy of multiple brain metastases using AGuIX® gadolinium-chelated polysiloxane based nanoparticles: a prospective randomized phase II clinical trial. - NANORAD2
Grenoble Alps University Hospital0 个研究点目标入组 100 人开始时间: 2018年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients with brain metastases, from a histologically confirmed solid tumor, eligible for WBRT
- •-At least 18 years old
- •-Signed informed consent after informing the patient
- •-ECOG (Eastern Cooperative Oncology Group) performans status 0-2
- •-Extracranial disease:
- •Complete or partial response or stability under systemic treatment
- •No extracranial disease
- •Or first line of treatment
- •- Life expectancy greater than 6 weeks
- •- No renal insufficiency
- •(glomerular filtration rate = 50 mL/min/1.73m²)
- •- Affiliated to a social security regimen
- •- Effective methods of contraception must be used throughout the study .
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •-Leptomeningeal metastasis
- •-Evidence of metastasis with recent large hemorrhage
- •-Progressive and threatening extracranial disease under systemic treatment
- •-Previous cranial irradiation (except stereotactic irradiation)
- •-Known contra-indication, sensitivity or allergy to gadolinium
- •-Known contra-indication for Magnetic Resonance Imaging
- •-Inclusion in another clinical trial protocol
- •-Pregnancy or breastfeeding
- •-Subject in exclusion period of another study
- •-Subject under administrative or judicial control
研究者
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