NCT02209948已完成2 期
Clinical Trial Phase IIB Randomized, Multicenter, of Continuation or Non Continuation With 6 Cycles of Temozolomide After the First 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
Grupo Español de Investigación en Neurooncología20 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2014年8月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 20
- 主要终点
- Progression Free Survival at 6 Month
研究概览
简要总结
The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles improve progression-free survival in patients with glioblastoma included in this study, randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and residual disease or not, to receive an additional 6 cycles of temozolomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and sign the informed consent document .
- •Age greater than or equal
- •Patients with glioblastoma according to WHO classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( Stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease.
- •Availability of tumor tissue from the first surgery for centralized histological review , for determining the MGMT study if you have not done in the center of origin. (If they were made in the center of origin the result of the center will be accepted ).
- •Stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant .
- •Index greater than or equal 60 % Karnofsky.
- •All patients must show no progression of disease in a brain nuclear magnetic resonance (NMR) as defined in RANO established criteria before randomization .
- •Basal NMR study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle ( NMR performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed).
- •Adequate bone marrow reserve : hematocrit greater or equal 29% , white blood cell> 3,000 , RAN greater or equal 1,500 cells / ul , platelets greater or equal 100,000 cells / ul.
- •Creatinine <1.5 times the upper limit of normal (ULN) of the laboratory performing the analysis.
- •Serum bilirubin <1.5 / ULN; SGOT , SGPT < 2.5 times the upper limit of normal of the laboratory performing the analysis. Serum < 3/ULN alkaline phosphatases .
- •Effective contraceptive method in patients and their partners.
排除标准
- •Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted.
- •Concomitant treatment with other investigational agents (other concomitant bevacizumab) .
- •Presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth.
- •Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol.
- •Concurrent disease that prevents the continuation of temozolomide treatment.
- •Presence of leptomeningeal dissemination.
- •Pregnant or breastfeeding.
- •Positive patients receiving combination antiretroviral therapy in HIV
研究组 & 干预措施
Temozolomide
Experimental
Those patients will take 6 additional Temozolomide cycles
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression Free Survival at 6 Month
时间窗: 6 month
Percentage of patients without progression of disease and time between start of treatment and progression of disease. The progression disease is defined as the time from the date of randomization to the date of progression defined according to the RANO criteria.
次要结局
- Translational Sub-study - Biomarkers: mutS Homolog 6 (MSH6) Immunoreactivity(baseline)
- Number of Participants With Adverse Effects(Through the whole study. 4 years)
- Overall Survival(Through the whole study. 4 years. The median follow up for each patient was 33.4 months)
- Median Overall Survival (OS) by Arm and MGMT Methylation Status(Through the whole study. 4 years. The median follow up for each patient was 33.4 months)
- Progresion Free Survival Median Values(Through the whole study. 4 years. The median follow up for each patient was 33.4 months)
- Median Progression-free Survival (PFS) by Arm and MGMT Methylation Status(Through the whole study. 4 years. The median follow up for each patient was 33.4 months)
研究者
研究点 (20)
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