NCT00004015已完成1 期
Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility
European Organisation for Research and Treatment of Cancer - EORTC16 个研究点 分布在 6 个国家目标入组 36 人开始时间: 2002年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 16
- 主要终点
- Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration
研究概览
简要总结
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.
详细描述
OBJECTIVES:
- Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy (BNCT) following craniotomy with gross total resection in patients with glioblastoma multiforme.
- Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients.
- Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions.
OUTLINE: This is a dose escalation, multicenter study.
Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation. Treatment repeats daily for 4 days.
Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven glioblastoma multiforme for which conventional radiotherapy would be of little or no benefit
- •Gross total resection of tumor confirmed by postoperative MRI performed within 48 hours of surgery
- •Evaluable preoperative and postoperative MRI films with and without contrast must be available
- •No prior brain malignancy
- •No prior craniotomy except for glioblastoma
- •PATIENT CHARACTERISTICS:
- •50 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin, SGOT, SGPT, and alkaline phosphatase no greater than 2.5 times normal unless caused by reversible reaction to antiseizure medication
- •Blood urea nitrogen and creatinine no greater than 2.5 times upper limit of normal
- •Cardiovascular:
- •No severe heart disease (e.g., congestive heart failure, angina pectoris)
- •No severe dyspnea at time of diagnosis
- •No severe obstructive or restrictive lung disease
- •No other concurrent malignant tumor
- •No severe gastrointestinal disease or active peptic ulcer disease
- •No uncontrolled endocrine disease
- •No serious mental disease, organic brain disease (e.g., preexisting epilepsy or serious aphasia), or legally incapacitated patients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy for glioblastoma multiforme
- •No concurrent biologic therapy
- •Chemotherapy:
- •No prior chemotherapy for glioblastoma multiforme
- •No concurrent chemotherapy
- •Endocrine therapy:
- •No prior endocrine therapy for glioblastoma multiforme except corticosteroids
- •No concurrent endocrine therapy
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy for glioblastoma multiforme
- •No prior radiotherapy to head and neck
- •No other concurrent radiotherapy
- •See Disease Characteristics
- •Prior stereotactic biopsy allowed for glioblastoma multiforme
排除标准
- 未提供
结局指标
主要结局
Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration
次要结局
- Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death
- Overall survival as measured by Logrank until death
研究者
研究点 (16)
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