GlioblastomaPhase 3NCT05439278
Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma
A Phase 3 study testing Hypofractionated radiotherapy, Conventional radiotherapy and Temozolomide in people with Glioblastoma, run by Severance Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Hypofractionated radiotherapy, Conventional radiotherapy and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2025to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul
Chan Woo Wee, MD, PhD, +82-2-2228-8121, wcw0108@yuhs.ac
About this study
Official title: Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
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.
- Conditions
- Glioblastoma
- Being tested
- Hypofractionated radiotherapy, Conventional radiotherapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
40.05 Gy in 15 fractions (daily treatment, 5 per week)
Conventional radiotherapyRadiation
60 Gy in 30 fractions (daily treatment, 5 per week)
TemozolomideDrug
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiochemotherapy | Experimental | Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) Receives: Radiation: Hypofractionated radiotherapy; Drug: Temozolomide |
| Conventional radiochemotherapy | Experimental | Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) Receives: Radiation: Conventional radiotherapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
from randomization
Measured: follow-up until 2 years
Secondary outcomes (3)
progression-free survival
from randomization
Measured: follow-up until 2 years
treatment-related toxicity
any treatment-related toxicity
Measured: 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
Measured: follow-up until 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Woo Wee, M.D., Ph.D, Severance Hospital
- Investigators
- Chan Woo Wee, MD, PhD, Study chair, Severance HospitalIn Ah Kim, MD, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439278
- Sponsor's protocol ID
- KROG 21-11
- Status last verified
- May 2025
- First submitted
- 21 Jun 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT05439278
- Acronym / sponsor ID
- KROG 21-11
- Conditions
- Glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiochemotherapy | Experimental | Radiation: Hypofractionated radiotherapy, Drug: TemozolomideRadiotherapy: 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: TemozolomideRadiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapy40.05 Gy in 15 fractions (daily treatment, 5 per week) | Radiation | Hypofractionated radiochemotherapy |
| Conventional radiotherapy60 Gy in 30 fractions (daily treatment, 5 per week) | Radiation | Conventional radiochemotherapy |
| Temozolomideconcurrent (75 mg/m2/day qd) and adjuvant (6 cycles) | Drug | Conventional radiochemotherapy, Hypofractionated radiochemotherapy |
Primary outcome
Overall survival
Time frame: follow-up until 2 years
from randomization
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chan Woo Wee, MD, PhD study chair
Severance Hospital
In Ah Kim, MD, PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypofractionated radiotherapy, Conventional radiotherapy and Temozolomide in people with Glioblastoma, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chan Woo Wee, MD, PhD (+82-2-2228-8121, wcw0108@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: follow-up until 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.