Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- partial response
研究概览
简要总结
The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate.
The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •giving their informed consent
- •having a supratentorial malignant glioma, either grade 4 of St. Anne/Mayo grading, or glioblastoma multiforme according to WHO classification
- •having an inoperable brain tumor (diagnosed by stereotactic biopsy)
- •having a general status, evaluated by Karnofsky scale, >60
- •having a life expectancy >3 months
- •not having previously had a brain irradiation and/or adjuvant or neo-adjuvant chemotherapy
- •potentially having another cancer, if histology and clinical history are available for comparison
- •being able to take oral tablets
- •no HIV disease
- •satisfactory hematology, hepatic and renal functions: polymorphonuclear neutrophils >1500/mm3, platelets >100000/mm3, Hb >8g/dl, creatinemia ≤1.5 times upper normal value, total bilirubin <1.5 times upper normal value, ASAT and ALAT <3 times upper normal value
- •for women of childbearing potential, a contraception is given
排除标准
- •having an under tentorial malignant glioma (brain stem and/or cerebellum), grade 4 of St. Anne/Mayo grading
- •having a Karnofsky score <60
- •having a life expectancy <3 months
- •having had a brain irradiation or an adjuvant or neoadjuvant chemotherapy
- •refusing any additional therapy
- •having a non-malignant but serious systemic disease or uncontrolled active infection
- •having a severe psychiatric disorder
- •not having signed the informed consent
- •pregnant or breastfeeding woman
研究组 & 干预措施
ultrafractionated brain irradiation - temozolomide
干预措施: Ultrafractionated brain irradiation (Radiation)
ultrafractionated brain irradiation - temozolomide
干预措施: Temozolomide (Drug)
结局指标
主要结局
partial response
时间窗: through study completion, 2 years
defined by at least 50% diminution of tumor size, evaluated by the product of 2 perpendicular diameters measured by MRI, with stability or amelioration of neurological status of patient receiving stable or reduced corticoid doses
progression
时间窗: through study completion, 2 years
defined by increase of at least 25% of tumor size and/or a second brain localization in MRI, with degradation of neurological status of patient
complete response
时间窗: through study completion, 2 years
defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids
stabilization
时间窗: through study completion, 2 years
corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses
次要结局
- treatment tolerance(through study completion, 2 years)
- global survival(through study completion, 2 years)
- survival without tumor recurrence(through study completion, 2 years)
- life quality(through study completion, 2 years)