ACTRN12609000485235已完成3 期
Phase III Trial on concurrent and adjuvant Temozolomide chemotherapy in non 1p/19q deleted anaplastic glioma to evaluate overall survival.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 751
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 o limit（—）
- 性别
- All
入选标准
- •Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis AND absence of combined 1p/19q loss. Both of which must have been determined by either local testing or central review.
- •Newly diagnosed disease
- •Prior surgery for a low grade tumour is allowed, provided histological confirmation of an anaplastic tumour is present at the time of progression.
- •Tumour material available for central 1p/19q assessment, central O6-methylguanine-DNAmethyltransferase promotor methylation status assessment and central pathology review.
- •Patients must be on a stable or decreasing dose of steroids for at lease 2 weeks prior to ransomisation.
- •WHO performance status 0-2
- •Start of radiotherapy within 8 days of randomisation
- •Start of radiotherapy within 7 weeks of (49 days) of surgery
- •No prior chemotherapy (including no treatment with Carmustine or bis-chloronitrosourea (BCNU) containing wafers (Gliadel)
- •No prior radiotherapy to the brain
- •No concomitant treatment with other anti-cancer agents or with any other experimental agent
- •Adequate renal, haematological and hepatic function according to all the following laboratory values (to be performed within 14 days prior to randomisation):
- •Neutrophils > or = 1.5*1000000000 cells/l
- •Platelets > or = 100*1000000000 cells/l
- •Bilirubin<1.5 times upper limit of laboratory normal
- •Alkaline phosphatase, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 2.5 times upperlimit for laboratory normal
排除标准
- •Pregnant or breast feeding
- •Known Human Immunodeficiency Virus (HIV) infection, chronic hepatitis B or C infection.
- •Any medical condition that could interfere with follow-up, oral medication intake (eg. frequent vomiting, partial bowel obstruction)
- •Previous concurrent malignancies at other sites with the exemption of surgically cured carcinoma in situ of the cervix and non-melanoma skin cancer.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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