ACTRN12620000048987进行中（未招募）3 期
A multi-arm multi-stage, multi-centre, phase III (MAMS) platform trial that aims to assess hypotheses against a common standard-of-care control arm for the management of people with glioblastoma. Initial questions of interest are: QUESTION 1: whether to give metronomic temozolomide as soon as possible following surgery prior to chemoradiotherapy; and QUESTION 2: whether to give a plan for 6 cycles of standard schedule adjuvant temozolomide chemotherapy (5/28 day cycles) after chemoradiotherapy, or continue temozolomide until progression.
HMRC Clinical Trials Centre (CTC), University of Sydney0 个研究点目标入组 338 人开始时间: 2020年1月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 338
研究概览
简要总结
暂无简介。
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. Adults, aged 18 years and older, with newly diagnosed histologically confirmed grade IV malignant glioblastoma (any IDH mutation status) or glioma with molecular features of GBM (e.g. IDH-wildtype grade III high grade glioma, which have been confirmed to have the same prognosis as glioblastoma (grade IV) patients, and are now functionally treated as GBM39)
- •2. Adequate recovery from surgical resection
- •3. ECOG performance status of 0-2
- •4. Previous surgery for a low-grade glioma is allowed, if there was no radiation or chemotherapy administered at that time
- •5. Adequate bone marrow function (platelets greater than or equal to 100 x 109/L, ANC greater than or equal to 1.5 x 109/L)
- •6. Adequate liver function (ALT/AST less than 3 x ULN)
- •7. Adequate renal function (creatinine clearance greater than 30ml/min)
- •8. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
- •9. Signed, written informed consent
排除标准
- •1. Recurrence of glioblastoma
- •2. Comorbidities considered to provide a safety concern for use of TMZ, e.g. idiopathic
- •autoimmune thrombocytopenia or other haematological diease causing cytopaenias
- •3. Other contraindications to TMZ
- •4. Cranial irradiation within 2 years prior to registration
- •5. Other co-morbidities or conditions that may compromise assessment of key outcomes
- •6. History of another malignancy within 2 years prior to registration. Patients with adequately treated carcinoma-in-situ of the prostate, breast or cervix, melanoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive transitional cell carcinoma of the bladder or low grade prostate cancer not requiring treatment (ISUP 1; Gleason grade less than or equal to 6) may be included in this study.
- •7. Concurrent illness, including severe or chronic bacterial or viral infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety. Patients with adequately treated hepatitis B, hepatitis C or human immunodeficiency virus at low risk of acquired immunodeficiency syndrome-related outcomes may be included in this study.
- •8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
- •9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
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