Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	70 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05439278
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Seoul National University Boramae Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chan Woo Wee, MD, PhDIn Ah Kim, MD, PhD
Principal Investigator Affiliation	SMG-SNU Boramae Medical CenterSeoul National University Bundang Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: Hypofractionated radiochemotherapy

Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

Experimental: Conventional radiochemotherapy

Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

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)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Chan Woo Wee, MD, PhD

[email protected]

+82-2-870-1695

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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