EUCTR2006-001533-17-IT进行中（未招募）1 期
Phase III trial on concurrent and adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON intergroup trial. - ND
E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER0 个研究点目标入组 748 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 748
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review. Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression WHO performance status 0-2 Age ≥ 18 years All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding Before patient registration, written informed consent must be obtained, according to ICH/GCP, and national/local regulations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •known HIV infection, chronic hepatitis B or hepatitis C infection any other serious medical condition that can interfere with follow-up any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction) previous or concurrent malignancies at other sites with the exception 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; those conditions should be discussed with the patient before registration in the trial prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel) prior radiotherapy to the brain
研究者
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