ISRCTN77105850已完成2 期
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)
niversity College London (UK)0 个研究点目标入组 120 人开始时间: 2011年6月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. The patient is reviewed at a specialist neuro-oncology multi-disciplinary team (MDT).
- •2. Preop MRI should be carried out, ideally on no or stable steroids according to RANO criteria
- •3. Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of a primary GBM
- •4. 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)
- •5. WHO performance status 0 or 1
- •6. Age =18
- •7. Patient judged by MDT to be fit for standard radical aggressive therapy for GBM (resection followed by RT with concomitant and adjuvant temozolomide)
排除标准
- •1. GBM thought to be transformed low grade or secondary disease
- •2. The patient has not been seen by a specialist MDT.
- •3. There is uncertainty about the radiological diagnosis
- •4. 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)
- •5. Pregnant or lactating women
- •6. Known or suspected HIV or other significant infection or comorbidity that would preclude radical aggressive therapy for GBM
- •7. Active liver disease (ALT or AST =5 x ULRR)
- •8. Concomitant anti-cancer therapy except steroids
- •9. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years
- •10. Previous brain surgery (including biopsy) or cranial radiotherapy
- •11. Platelets <100 x109/L
- •12. Mini mental status score <15
研究者
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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)Primary glioblastomaMedDRA version: 14.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022496-66-GBJoint UCLH and UCL Biomedical Research Unit
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