NCT00643825Unknown2 期
Randomized Multicentric Phase II Study of Prolonged Adjuvant Temozolomide or "Stop and Go" in Glioblastoma Patients: The PATSGO Study
Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months
研究概览
简要总结
This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).
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
- •Patients with histologically confirmed diagnosis of GBM
- •Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended
- •Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy.
- •A brain MRI with or without a PET-Scan-methionine must be performed before enrolment.
- •Age ≥ 18 years
- •Karnofsky Performance status ≥ 60
- •Normal haematological functions: ANC ≥ 1.5 x 109cells/l, platelets ≥ 100 x 109 cells/l
- •Normal liver function: total bilirubin < 1.5 x ULN, alkaline phosphatase and transaminases (ASAT/ALAT) < 2.5 times the upper limit of the normal range
- •Serum creatinine < 1.5 x ULN
- •Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia
- •No previous or current malignancy (except treated basal or squamous cell skin carcinoma, cervix cancer or in situ carcinoma of the breast).
- •All patients (male and female) with reproductive potential must use effective contraception. Females must have a negative serum pregnancy test at entry to study.
- •Signed informed consent from the patient or legal representative must be obtained.
排除标准
- •All non inclusion criteria
研究组 & 干预措施
A: prolonged adj TMZ
Active Comparator
干预措施: Temozolomide (Drug)
B : Stop and Go
Other
Rechallenging patients with TMZ at relapse
干预措施: Temozolomide (Drug)
结局指标
主要结局
to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months
时间窗: 36 months
次要结局
- safety and adverse event profile of prolonged adjuvant Temozolomide(3 years)
研究者
研究点 (1)
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