EUCTR2006-001533-17-FR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.
EORTC European Organisation for research and treatment of cancer0 个研究点目标入组 748 人开始时间: 2007年5月29日最近更新:
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
- 性别
- All
入选标准
- •The combination of :
- •Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis
- •Absence of combined 1p/19q loss
- •both of which must have been determined by either local testing or central review
- •Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review
- •WHO performance status 0-2
- •Age = 18 years
- •Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
- •Start of radiotherapy within 8 days from randomization
- •Start of radiotherapy within 7 weeks (49 days) from surgery
- •Patients must be on a stable or decreasing dose of steroids for at least two weeks
- •No prior chemotherapy (including no treatment with 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 hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days prior to randomization):
- •neutrophils greater or equal to 1.5*109 cells/l
- •platelets greater or equal to 100*109 cells/l
- •bilirubin < 1.5 times upper limit of laboratory normal
- •alkaline phosphatase, ASAT and ALAT <2.5 times upper limit of laboratory normal
- •serum creatinine lower than 1.5 times upper limit of laboratory normal
- •All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
- •Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
- •Absence of any other serious medical condition that could interfere with follow-up
- •Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
- •Absence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ of te cervix and non-melanoma skin cancer.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Patients can only be randomized in this trial once.
- •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
- 未提供
研究者
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