Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

NCT05439278 — Phase 3, Recruiting, 178 participants, Severance Hospital

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Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients

Registry	NCT05439278
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	178 (Estimated)
Sponsor	Severance Hospital (Other)
Conditions	Glioblastoma
Interventions	Hypofractionated radiotherapy, Conventional radiotherapy, Temozolomide (Radiation, drug)
Dates	start 2025-02-01, primary completion 2028-12-31 (estimated), completion 2030-12-31 (estimated), first posted 2022-06-30, last updated 2025-05-21
Locations	1 site in South Korea

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Hypofractionated radiochemotherapy	Experimental	Radiation: Hypofractionated radiotherapy; Drug: Temozolomide	Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Conventional radiochemotherapy	Experimental	Radiation: Conventional 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)

Hypofractionated radiotherapy (Radiation): 40.05 Gy in 15 fractions (daily treatment, 5 per week)
Conventional radiotherapy (Radiation): 60 Gy in 30 fractions (daily treatment, 5 per week)
Temozolomide (Drug): concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

+Outcome measures

Primary outcomes

Overall survival [follow-up until 2 years]: from randomization

Secondary outcomes

progression-free survival [follow-up until 2 years]: from randomization
treatment-related toxicity [follow-up until 2 years]: any treatment-related toxicity
patient-reported quality of life [follow-up until 2 years]: 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

+Eligibility

Sex: All, ages: 70 Years to any

Inclusion Criteria:

* newly diagnosed glioblastoma according to the 2021 World Health Organization classification
* interval of ≤4 weeks between pathological diagnosis and randomization
* aged 70 years or older
* gadolinium-enhanced MRI within 72 hours of surgery
* known o6-methylguanine-DNA-methyltransferase promoter methylation status
* Karnofsky performance score ≥60
* stable or decreasing dose of steroid (if necessary)
* no history of brain radiotherapy
* no history of any systemic chemotherapy
* adequate hematological, renal and hepatic functions for temozolomide
* able to start radiotherapy within 3 weeks from randomization

Exclusion Criteria:

* patients with spinal leptomeningeal carcinomatosis
* history of cancer other than the followings:
* carcinoma in situ of the cervix
* completely excised non-melanoma skin cancer
* cancers without any evidence of residual disease for 5 years or longer
* patients with serious active infection or other serious underlying medical conditions
* patients with psychological issues that cannot comply to the protocol
* patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
* patients who are currently participating in other clinical trials

+Locations (1)

Facility	City	Country	Status
Severance hospital	Seoul	South Korea	Recruiting

+Investigators

Chan Woo Wee, MD, PhD, Study chair, Severance Hospital
In Ah Kim, MD, PhD, Study chair, Seoul National University Bundang Hospital