The CONCISE trial: Condensed Chemoradiotherapy Schedule for Glioblastoma
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
The Walter and Eliza Hall Institute of Medical Research (WEHI)
330 participants
Jun 1, 2026
Interventional
Conditions
Summary
This study aims to examine the impact of hypofractionated radiotherapy (HF-RT), which involves delivering radiotherapy over a more intensive schedule, in patients 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, histologically confirmed WHO (5th edition, 2021) Grade 4 GBM, IDH-wildtype, and have been placed on Stupp protocol for treatment. Study details Participants will be randomly allocated to either receive 4 weeks of hypofractionated radiotherapy (55 Gy in 20 daily fractions, 5 days per week), or 6 weeks of conventionally fractionated radiotherapy (60 Gy 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 patients. It is hoped that findings from this study will help provide valuable data to researchers on the utility of HF-RT in glioblastoma patients.
Eligibility
Inclusion Criteria7
- Age 18-70 years
- Newly diagnosed, histologically confirmed WHO (5th edition, 2021) Grade 4 Glioblastoma (GBM), Isocitrate dehydrogenase (IDH) wildtype.
- O6-Methylguanine-DNA methyltransferase (MGMT) promoter methylation status available or will be available
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- 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)
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- Able to provide written informed consent.
Exclusion Criteria3
- Comorbidities or conditions (e.g. psychiatric) that may compromise assessment of key outcomes
- TMZ or cranial RT in the last five years prior to GBM diagnosis
- 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
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Interventions
This study compares two standards of care for radiotherapy in combination with temozolomide (TMZ). Investigational Arm • Hypo fractionated radiotherapy, 55 Gy delivered in 20 daily fractions over 4 weeks (5 fractions per week). Comparative (Standard of Care) Arm: • Conventional fractionated radiotherapy, 60 Gy delivered in 30 daily fractions over 6 weeks (5 fractions per week). Participants in both treatment arms will receive standard-of-care temozolomide chemotherapy administered concurrently with radiotherapy and as adjuvant therapy. Concurrent Temozolomide • Initiation: Concurrent during radiotherapy • Dose: 75 mg/m² orally once daily • Schedule: 7 days per week, including weekends • Duration: Throughout the course of radiotherapy Adjuvant Temozolomide • Adjuvant temozolomide will be initiated approximately 4 weeks (± 1 week) after completion of concurrent radiotherapy and temozolomide in both the Investigational and Comparative arms. • Adjuvant temozolomide in both arms must commence no later than 6 weeks after completion of concurrent RT + TMZ. • Dose: 150–200 mg/m² orally, based on prior tolerance • Schedule: Days 1–5 of each 28-day cycle • Duration: 6 cycles Temozolomide is administered as an oral capsule taken for five consecutive days in each 28-day cycle at the dose previously tolerated by the patient. Treatment adherence will be monitored during four-weekly clinical assessments. The study will also involve a focus on patient and carer-reported outcomes as well as an embedded health-economic analysis.
Locations(1)
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ACTRN12626000036314