EUCTR2010-022496-66-GB进行中（未招募）不适用
An Evaluation of the Tolerability and Feasibility of combining 5-Amino-Levulinic Acid (5-ALA) with Carmustine Wafers (Gliadel) in the Surgical Management of Primary Glioblastoma (GALA-5 Trial) - Feasibility of 5-ALA and Carmustine wafers for Glioblastoma (GALA-5)
Joint UCLH and UCL Biomedical Research Unit0 个研究点开始时间: 2011年1月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •The patient is reviewed at a specialist neuro-oncology MDT. • Preop stealth MRI should be carried out on no or stable steroids according to RANO criteria • Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of a primary GBM • Radical resection is judged to be realistic by the neurosurgeons at the MDT (i.e. NICE criteria for the use of Carmustine wafers can be met) • WHO performance status 0 or 1 • Age =18 • Patient judged by MDT to be fit for standard radical aggressive therapy for GBM (resection followed by RT with concomitant and adjuvant temozolomide)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •GBM thought to be transformed low grade or secondary disease • The patient has not been seen by a specialist MDT. • There is uncertainty about the radiological diagnosis • 5-ALA or Carmustine wafers is contra-indicated (inc known or suspected allergies to 5-ALA or porphyrins, or acute or chronic types of porphyria) • Pregnant or lactating women • Known or suspected HIV or other significant infection or comorbidity that would preclude radical aggressive therapy for GBM • Active liver disease (ALT or AST =5 x ULRR) • Concomitant anti-cancer therapy except steroids • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years • Previous brain surgery (including biopsy) or cranial radiotherapy • Platelets <100 x10_9/L • Mini mental status score <15
研究者
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