Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme (TEMOFRAC)
2017年10月16日 更新者：Central Hospital, Nancy, France
Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
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.
研究概览
研究类型
介入性
注册 (实际的)
46
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 74年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ultrafractionated brain irradiation - temozolomide
|
0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)
75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
complete response
大体时间：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
|
through study completion, 2 years
|
|
partial response
大体时间：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
|
through study completion, 2 years
|
|
stabilization
大体时间：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
|
through study completion, 2 years
|
|
progression
大体时间：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
|
through study completion, 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
global survival
大体时间：through study completion, 2 years
|
through study completion, 2 years
|
|
|
treatment tolerance
大体时间：through study completion, 2 years
|
evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC)
|
through study completion, 2 years
|
|
survival without tumor recurrence
大体时间：through study completion, 2 years
|
tumor recurrence detected with radiology examination
|
through study completion, 2 years
|
|
life quality
大体时间：through study completion, 2 years
|
evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30)
|
through study completion, 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2008年2月13日
初级完成 (实际的)
2012年6月26日
研究完成 (实际的)
2012年6月26日
研究注册日期
首次提交
2017年10月11日
首先提交符合 QC 标准的
2017年10月11日
首次发布 (实际的)
2017年10月16日
研究记录更新
最后更新发布 (实际的)
2017年10月17日
上次提交的符合 QC 标准的更新
2017年10月16日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.