ACTRN12618001944224已完成3 期
To determine if extended post-radiation temozolomide will improve survival outcomes in patients with newly diagnosed glioblastoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
研究概览
简要总结
In order to reach sufficient numbers for analysis, the individual patient data for the EX-TEM study was combined with the individual patient data of a Spanish study that used a near identical protocol, GEINO14-01 study Results from the study concluded patients with newly diagnosed glioblastoma, extending post-radiation temozolomide from 6 to 12 months is well tolerated but does not improve 6 month progression free survival. We could not identify any individual patient subset that appeared to benefit from extended treatment. Six months of temozolomide should remain standard of care.
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
- •1.Males or females with newly diagnosed, histologically confirmed glioblastoma
- •2.Adults, aged 18 years and over
- •3.Completed radiation plus concurrent temozolomide, followed by six cycles of post-radiation temozolomide
- •4.No evidence of progressive disease on on-study screening MRI. Residual disease or enhancement is allowed, as long as stability or response according to RANO criteria has been demonstrated compared with prior MRI
- •5.ECOG 0-2
- •6.Life expectancy of > 12 weeks
- •7.Fit for further temozolomide
- •8.Able to start study treatment within four weeks of day one of cycle six
- •9.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •10.Signed, written informed consent.
排除标准
- •1.Progressive disease on on-study screening MRI according to RANO criteria when compared with prior MRI
- •2.Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the administration of study treatments or procedures
- •3.Other comorbidities or conditions that may compromise assessment of key outcomes
- •4.No temozolomide or cranial irradiation in the last five years prior to GBM diagnosis.
- •5.History of another malignancy within five years prior to registration. Patients with curatively treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or superficial transitional cell carcinoma of the bladder are eligible.
- •6.Significant infection, including chronic active hepatitis B, hepatitis C or HIV.
- •7.Concurrent illness,
- •8.Pregnancy, lactation, or inadequate contraception.
研究者
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