ACTRN12607000427471进行中（未招募）3 期
Trans Tasman Radiation Oncology Group (TROG) 06.01 - Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study to demonstrate a difference in progression free survival.
European Organisation for Research and Tretment of Cancer (EORTC)0 个研究点目标入组 709 人开始时间: 2007年8月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 709
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 -2147483648 No limit（—）
- 性别
- All
入选标准
- •At registration:
- •- Histologically proven low grade diffuse glioma astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic)
- •oligoastrocytoma WHO grade II oligodendroglioma WHO II
- •- Supratentorial location only
- •- WHO performance status = 2
- •- Not candidate for treatment exclusively by surgery
- •- RTOG neurological function 0-3
- •- Results of genetic testing (1p) available
- •- Adequate haematological, renal and hepatic function
- •- Histopathologic slides available for central pathology review
- •- Tumour material (paraffin-embedded) and blood available for molecular testing
- •- Written informed consent
- •At randomisation:
- •Same as above PLUS
- •- Requiring treatment as demonstrated by at least one of the following criteria (1-4):
- •1. Age = 40 years
- •2. Radiologically proven progressive lesion
- •3. New or worsening neurological symptoms other than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits)
- •4. Intractable seizures, defined as having both:
- •persistent seizures interfering with everyday life activities other than driving a car
- •failed three lines of anti-epileptic drug regimen, including at least one combination regimen
- •- RTOG Neurological Function 0-3
- •- Not candidate for treatment exclusively with surgery
- •- Must have recovered from any prior surgery
- •- 1p test result available (for stratification: 1p deleted versus 1p normal versus undeterminable)
- •- Baseline quality of life questionnaires (QLQ-C30 + BN20) completed
- •- Prepared to use effective contraception for the duration of the treatment and for 6 months after(applies to all patients with reproductive potential - male and female)
排除标准
- •- Previous irradiation of the brain
- •- Previous chemotherapy
- •- Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer
- •- Known HIV infection, chronic hepatitis B or hepatitis C infection
- •- Any other serious medical contraindication as per the judgment of the treating physician
- •- Any medical condition which could interfere with oral medication intake (e.g. frequent vomiting, partial bowel obstruction)
- •- Female pregnant or lactating
- •- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before randomization
研究者
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