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Not yet recruitingLast updated: 29 May 2026

CONCISE: Testing whether a more intensive schedule of radiation therapy improves outcomes for people with newly diagnosed Grade 4 glioblastomaTo determine whether hypofractionated radiotherapy (HF-RT) combined with concurrent and adjuvant temozolomide (TMZ) provides survival outcomes that are not inferior to those of conventional fractionated radiotherapy (CF-RT) with concurrent and adjuvant TMZ in adults with newly diagnosed Grade 4 Glioblastoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Brain and Spinal Cancers Brain and Spinal

Age

People18 - 70

Trial acronym

CONCISE

Clinical summary

Summary

This study aims to examine the impact of hypofractionated radiotherapy (HF-RT), which involves delivering radiation therapy over a more intensive schedule, in people with newly diagnosed Grade 4 glioblastoma.

Who is it for?
You may be eligible for this study if you are aged 18 to 70 years, and have a newly diagnosed grade 4 glioblastoma (GBM), and have been placed on Stupp protocol for treatment.

Study details
Participants will be randomly allocated (by chance) to either receive:

  • 4 weeks of hypofractionated radiotherapy - 55Gy in 20 daily fractions, 5 days per week
  • 6 weeks of convetionally fractionated radiotherapy - 60Gy in 30 daily fractions, 5 days per week

Both arms will also receive concurrent and adjuvant temozolomide chemotherapy. 

Data on survival, health-related quality of life and healthcare resourcing will be collected from all participants.

It is hoped that findings from this study will help provide valuable data to researchers on the utility of HF-RT in glioblastoma patients.

Conditions

This trial is treating people with newly diagnosed Grade 4 glioblastoma (GBM) IDH wildtype

Eligibility

Inclusion

1. Age 18-70 years

2. Newly diagnosed, histologically confirmed WHO (5th edition, 2021) Grade 4 Glioblastoma (GBM), Isocitrate dehydrogenase (IDH) wildtype.

3. O6-Methylguanine-DNA methyltransferase (MGMT) promoter methylation status available or will be available

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

5. Suitable for European Organisation for Research and Treatment of Cancer/National Cancer Information Centre (EORTC-NCIC) “Stupp” protocol treatment (concurrent RT+TMZ and adjuvant TMZ)

6. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments

7. Able to provide written informed consent.

Exclusion

 

1. Comorbidities or conditions (e.g. psychiatric) that may compromise assessment of key outcomes
2. TMZ or cranial RT in the last five years prior to GBM diagnosis
3. 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. Patients with a history of other malignancies are eligible if they have been disease free for at least five years after definitive primary treatment

Inclusion

  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

The Walter and Eliza Hall Institute of Medical Research (WEHI)

Scientific Title

To determine whether hypofractionated radiotherapy (HF-RT) combined with concurrent and adjuvant temozolomide (TMZ) provides survival outcomes that are not inferior to those of conventional fractionated radiotherapy (CF-RT) with concurrent and adjuvant TMZ in adults with newly diagnosed Grade 4 Glioblastoma

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