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Keyword: MAGMA
Broad Health Condition: Cancer
Specific Condition: Brain
Recruitment Status: Recruiting

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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 or 12 cycles of temozolomide after chemoradiotherapy.

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Trial Information

Trial summary

This study aims to evaluate the use of temozolomide in different regimes for Glioblastoma. The trial is testing two changes to the usual schedule of treatment.

Who is it for?

You may eligible for this study if you are a male or female aged 18 years or older, with newly diagnosed, histologically confirmed grade IV malignant glioblastoma.

For the initial questions of interest, participants will be randomly allocated (50/50) chance to one of two treatment groups, to either

QUESTION 1:
Intervention Arm 1: After surgery, start temozolomide as soon as possible prior to chemoradiotherapy
Control Arm 2: After surgery, start temozolomide at the same time as radiotherapy


QUESTION 2:
Intervention Arm 1: After chemoradiotherapy, take adjuvant temozolomide until disease progression 
Control Arm 2: After chemoradiotherapy, take adjuvant temozolomide for 6 cycles 

For participants that choose not to be randomly allocated treatment will be at patient/doctor discretion. 

All participants will be asked to have blood tests and scans as you would for usual treatment, the extra things requested are to fill out questionnaires and donate extra blood tests. 

It is hoped this research will help identify if starting temozolomide earlier than usual and/or continuing treatment with temozolomide for longer than usual will improve the outcomes of people with glioblastoma and assist development of future treatments. 

Broad Health ConditionGlioblastoma

Specific Health ConditionCancer
Brain

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,TAS,WA,VIC

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Gold Coast University Hospital - Southport

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Royal Hobart Hospital - Hobart

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Concord Repatriation Hospital - Concord

Hospital
Liverpool Hospital - Liverpool

Hospital
St George Hospital - Kogarah

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
The Townsville Hospital - Douglas

Hospital
Prince of Wales Hospital - Randwick

Hospital
Nepean Hospital - Kingswood

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Westmead Hospital - Westmead

Hospital
Coffs Harbour Base Hospital - Coffs Harbour

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Flinders Medical Centre - Bedford Park

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Gosford Hospital - Gosford

Postcode
2298 - Waratah

Postcode
4215 - Southport

Postcode
6009 - Nedlands

Postcode
7000 - Hobart

Postcode
2065 - St Leonards

Postcode
2139 - Concord

Postcode
2170 - Liverpool

Postcode
2217 - Kogarah

Postcode
4029 - Herston

Postcode
4102 - Woolloongabba

Postcode
4814 - Douglas

Postcode
2031 - Randwick

Postcode
2747 - Kingswood

Postcode
3065 - Fitzroy

Postcode
3084 - Heidelberg

Postcode
2145 - Westmead

Postcode
2450 - Coffs Harbour

Postcode
3000 - Melbourne

Postcode
3168 - Clayton

Postcode
5042 - Bedford Park

Postcode
2010 - Darlinghurst

Postcode
2050 - Camperdown

Postcode
2250 - Gosford

Anticipated date of first participant enrolment30/06/2020

Anticipated date of last participant enrolment30/06/2023

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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. 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: NHMRC Clinical Trials Centre (CTC), University of Sydney
Primary Sponsor Address: The University of Sydney (USYD), City Rd, Darlington New South Wales 2008
Primary Sponsor Country: Australia

Trial websitehttps://www.cogno.org.au/content.aspx?page=currenttrials

Trial IDACTRN12620000048987

Contact person for information and recruitmentDr
MAGMA Trial Operations Coordinator
NHMRC Clinical Trials Centre The Lifehouse Building, Level 6, 119-143 Missenden Road Camperdown, NSW, 2050
+61 2 9562 5000

Further information iconmagma@ctc.usyd.edu.au
Australia