Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated radiotherapy, Conventional radiotherapy, Temozolomide.
- Who it may be relevant to
- Registry conditions: Glioblastoma. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
Overview
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.
Interventions
- Radiation Hypofractionated radiotherapy
40.05 Gy in 15 fractions (daily treatment, 5 per week) - Radiation Conventional radiotherapy
60 Gy in 30 fractions (daily treatment, 5 per week) - Drug Temozolomide
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Primary outcome measures
- Overall survival [Time frame: follow-up until 2 years]
Secondary outcome measures (3)
- progression-free survival [Time frame: follow-up until 2 years]
- treatment-related toxicity [Time frame: follow-up until 2 years]
- patient-reported quality of life [Time frame: follow-up until 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Severance hospital — Seoul
Identifiers
NCT: NCT05439278 · KROG 21-11