Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0
研究概览
简要总结
Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
详细描述
Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery.
Imaging:
MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery.
MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population)
- •WHO performance status 0-2 (to allow comparison to historical controls)
- •Adequate hematological parameters: (for safety because of neutropenia from the temozolomide)
- •Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent)
- •Able to have MRI scans (secondary endpoint is MRI scan characteristics)
- •Willing to have radiation treatment at a participating center (homogeneity of treatment parameters)
- •Ages 18-80
排除标准
- •Unresectable tumor
- •Absolute neutrophil count (ANC) less than 1,200/μL
- •Hemoglobin less than 9.0g/dL
- •Platelet count less than 100,000/μL
研究组 & 干预措施
Preoperative chemoradiation
Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
干预措施: Temozolomide (Drug)
Preoperative chemoradiation
Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
干预措施: partial brain irradiation (Radiation)
Preoperative chemoradiation
Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
干预措施: stereotactic biopsy of brain tumor (Procedure)
Preoperative chemoradiation
Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
干预措施: craniotomy and tumor resection (Procedure)
结局指标
主要结局
toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0
时间窗: up to up to 16 weeks
comparison of toxicity related to experimental treatment to historical local controls
次要结局
- Feasibility of measurement of O(6)-Methylguanine-DNA methyltransferase (MGMT) activity on stereotactic samples(at enrollment)
- progression free survival(up to 12 months)
- overall survival(up to 12 months)