EUCTR2006-001533-17-GB进行中（未招募）不适用
Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial. - CATNO
EORTC European Organisation for research and treatment of cancer0 个研究点目标入组 748 人开始时间: 2009年9月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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
- •AT REGISTRATION :
- •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
- •WHO performance status 0-2
- •Age = 18 years
- •All patients must use effective contraception id 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 can 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 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.
- •RANDOMIZATION:
- •The combination of 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.
- •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 (extra 2 days could be allowed).
- •Patients must be on a stable or decreasing dose of steroids for at least two weeks.
- •Adequate hematological, renal and hepatic function.
- •All patients, must use effective contreception 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.
- •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 748
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Privious other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to registration; and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix.
- •Prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®)
- •Prior radiotherapy to the brain
- •RANDOMIZATION:
- •Prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®).
- •Prior radiotherapy to the brain.
研究者
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