EUCTR2006-001533-17-BE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. - CATNO
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
- EORTC
- 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 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 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 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
- •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
- •REGISTRATION:
- •- Previous 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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