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ID:56
Study Name:GLIOFOCUS
Iras Number:1010468
Study Type:Interventional
Anatomical Region:Head and Neck
Disease Site:Brain
Study Status:Open
Site Location:
The Christie NHS Foundation Trust
Wilmslow Road, Manchester, M20 4BX
The Christie NHS Foundation Trust
Full Study Title:
A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma
Research Summary:

The GlioFocus study is an international Phase 3 clinical trial for adults who have been newly diagnosed with glioblastoma that is MGMT‑unmethylated, a type of tumour that does not respond well to standard chemotherapy. The study is comparing a newer targeted cancer drug, niraparib, with the usual chemotherapy drug temozolomide, and both treatments are given alongside standard radiotherapy


Participants are randomly assigned to receive either niraparib plus radiotherapy or temozolomide plus radiotherapy. After the radiotherapy stage—which lasts about six to seven weeks—patients continue with the same study medication: niraparib is taken for as long as the cancer remains stable, while temozolomide continues for up to six additional cycles.


The study aims to find out whether niraparib can keep the cancer under control for longer and improve survival compared with temozolomide, as earlier research suggested niraparib may reach tumour tissue more effectively and may help extend life when combined with radiotherapy.


Around 450 patients will take part globally, and each participant may be involved in the study for several years, including long‑term follow‑up of up to five years after treatment to monitor their health and the longer‑term effects of therapy

Contact Information:
If you have interest in this study, please discuss this with your oncology healthcare team.
Date Site Open:
AUG
04
2025
Study End Date:
JAN
26
2028
✓ Randomisation
✓ Additional Appointments
Link to NIHR Database: Not provided