The Multi-Arm GlioblastoMa Australasia (MAGMA) Trial is a platform trial that will assess a number of options in standard of care for the management of glioblastoma. Initial questions of interest are: QUESTION 1 whether or not to give a cycle of temozolomide prior to chemoradiotherapy and QUESTION 2: whether to give 6 cycles of temozolomide after chemoradiotherapy, or continue monthly treatment until disease progressio
- Conditions
- GlioblastomaCancer - Brain
- Registration Number
- ACTRN12620000048987
- Lead Sponsor
- HMRC Clinical Trials Centre (CTC), University of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 338
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective for each investigational question is to assess the effectiveness of that treatment on overall survival versus usual care.[ Overall survival is defined as the interval from the date of initial surgery to the date of death from any cause, or censoring at the date of last known follow-up alive, and will be calculated using the Kaplan-Meier method. For the initial two questions of interest this timepoint will be assessed until 18 months follow-up. ]
- Secondary Outcome Measures
Name Time Method