A Phase 3 interventional study of Hypofractionated radiotherapy and Conventional radiotherapy in Glioblastoma, sponsored by Severance Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Severance Hospital · Phase 3, Interventional, and Treatment
In newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . The purpose of this study is to compare conventional radiotherapy of 60 Gy (6 weeks) versus hypofractionated radiotherapy of 40 Gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 178 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Severance Hospital is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Radiation: Hypofractionated radiotherapy · Drug: Temozolomide
Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Radiation: Conventional radiotherapy · Drug: Temozolomide
40.05 Gy in 15 fractions (daily treatment, 5 per week)
60 Gy in 30 fractions (daily treatment, 5 per week)
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Overall survival
from randomization
Time frame: follow-up until 2 years
progression-free survival
from randomization
Time frame: follow-up until 2 years
treatment-related toxicity
any treatment-related toxicity
Time frame: follow-up until 2 years
patient-reported quality of life
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 version 3.0): range, 0-100 (a high score for a functional scale represents a high / healthy level of functioning; a high score for the global health status / QoL represents a high QoL; a high score for a symptom scale / item represents a high level of symptomatology / problems) Quality of Life Questionnaire-Brain Neoplasm (EORTC QLQ-BN20): range, 20-80; lower score means better outcome
Time frame: follow-up until 2 years
Plan to share: No — There is no plan to make individual participant data available.
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Dec 2028, 46 months after the start.
Of 43 phase 3 interventional studies under Glioblastoma, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 87. This study's planned 46 months is close to that.
How these figures are worked out, and which studies are left out of them.
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