Glioblastoma (GBM)HipoGBMNCT07492836
Hypofractionated Radiotherapy Plus Temozolamide in Patients Younger Than 70 Years With Glioblastoma
A study testing Hypofractionated Radiation Therapy in people with Glioblastoma (GBM), run by Hospital do Coracao.
Trial summary
The goal of this clinical trial is to evaluate the feasibility, safety and effectiveness of radiotherapy with fewer days of treatment and a higher dose of radiation each day in patients under 70 years of age diagnosed with a brain tumor known as glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2029
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Initial histological diagnosis of glioblastoma
- Age > 18 and < 70 years;
- Karnofsky Performance Status > 70%;
- Patient consent to participate in the study.
Who cannot join
- Patients submitted to any type of previous radiotherapy in the cranial region;
- Multicentric tumors;
- Contraindication to chemotherapy with temozolomide;
- Contraindications for performing magnetic resonance imaging (MRI), such as the use of implants or metallic prostheses;
- Pregnant women or women of childbearing age who refuse to undergo the beta-HCG test before treatment and contraception during the intervention.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Pilot Study to Evaluate Hypofractionated Radiotherapy Associated With Temozolomide in Patients Aged 18 to 70 Years With Glioblastoma (HypoGBM)
The goal of this clinical trial is to evaluate the feasibility, safety and effectiveness of radiotherapy with fewer days of treatment and a higher dose of radiation each day in patients under 70 years of age diagnosed with a brain tumor known as glioblastoma.
Read the detailed description
The goal of this clinical trial is to evaluate the feasibility (accrual of patients, planning of radiotherapy), safety (acute and late neurological toxicity) and effectiveness (overall survival and progression free survival) of radiotherapy with fewer days of treatment and a higher dose of radiation each day (dose of 60 Gy in 20 fractions of 3 Gy) in patients between 18 and 70 years of age diagnosed with a brain tumor known as glioblastoma. Additionally, circulating tumor cells will be searched in the blood before and after radiotherapy and its quantitative and qualitative analysis will be correlated with the survival outcomes.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Hypofractionated Radiation Therapy
- Keywords
- Radiotherapy, Temozolamide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
60 Gy in 20 fractions of 3 Gy
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Hypofractonated Radiotherapy Receives: Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of accrual and planning
Accrual of patients, timely and adequated planning of radiotherapy
Measured: From enrollment to the end of planning of the 10 patients at 5 months
Incidence of acute and late neurological toxicity
Incidence of headache, brain edema and brain radionecrosis will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Weekly evaluation during treatment and at 4, 12, 24, 36 weeks in the first year and every 6 months until 3 years after radiotherapy.
Secondary outcomes (1)
Overall Survival and Progression Free Survival
Death from any cause and disease progression during treatment and follow-up time
Measured: Start of radiotherapy to the date of event (death or progression of disease) up tp 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma (GBM)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hypofractonated Radiotherapy with 60 Fy in 20 fractions of 3 Gy
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas G Castro, MD PhD, Principal investigator, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492836
- Sponsor's protocol ID
- 95122526.0.0000.0060
- Acronym
- HipoGBM
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial,
Publications
Muller Bark J, Kulasinghe A, Hartel G, Leo P, Warkiani ME, Jeffree RL, Chua B, Day BW, Punyadeera C. Isolation of Circulating Tumour Cells in Patients With Glioblastoma Using Spiral Microfluidic Technology - A Pilot Study. Front Oncol. 2021 Jun 3;11:681130. doi: 10.3389/fonc.2021.681130. eCollection 2021.
PubMed 34150645Mallick S, Gupta S, Amariyil A, Kunhiparambath H, Laviraj MA, Sharma S, Sagiraju HKR, Julka PK, Sharma D, Rath GK. Hypo-fractionated accelerated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed glioblastoma: updated results from phase II HART-GBM trial. J Neurooncol. 2023 Aug;164(1):141-146. doi: 10.1007/s11060-023-04391-7. Epub 2023 Jul 15.
PubMed 37452916Jastaniyah N, Murtha A, Pervez N, Le D, Roa W, Patel S, Mackenzie M, Fulton D, Field C, Ghosh S, Fallone G, Abdulkarim B. Phase I study of hypofractionated intensity modulated radiation therapy with concurrent and adjuvant temozolomide in patients with glioblastoma multiforme. Radiat Oncol. 2013 Feb 20;8:38. doi: 10.1186/1748-717X-8-38.
PubMed 23425509
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Pilot Study to Evaluate Hypofractionated Radiotherapy Associated With Temozolomide in Patients Aged 18 to 70 Years With Glioblastoma (HypoGBM)
- ClinicalTrials.gov ID
- NCT07492836
- Acronym / sponsor ID
- HipoGBM / 95122526.0.0000.0060
- Conditions
- Glioblastoma (GBM)
- Keywords
- Radiotherapy, Temozolamide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 25 Mar 2026 (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.
The goal of this clinical trial is to evaluate the feasibility, safety and effectiveness of radiotherapy with fewer days of treatment and a higher dose of radiation each day in patients under 70 years of age diagnosed with a brain tumor known as glioblastoma.
Detailed description
The goal of this clinical trial is to evaluate the feasibility (accrual of patients, planning of radiotherapy), safety (acute and late neurological toxicity) and effectiveness (overall survival and progression free survival) of radiotherapy with fewer days of treatment and a higher dose of radiation each day (dose of 60 Gy in 20 fractions of 3 Gy) in patients between 18 and 70 years of age diagnosed with a brain tumor known as glioblastoma. Additionally, circulating tumor cells will be searched in the blood before and after radiotherapy and its quantitative and qualitative analysis will be correlated with the survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hypofractonated Radiotherapy with 60 Fy in 20 fractions of 3 Gy
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Radiation: Hypofractionated Radiation TherapyHypofractonated Radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Initial histological diagnosis of glioblastoma
- Age > 18 and < 70 years;
- Karnofsky Performance Status > 70%;
- Patient consent to participate in the study.
Key exclusion criteria (5 listed)
- Patients submitted to any type of previous radiotherapy in the cranial region;
- Multicentric tumors;
- Contraindication to chemotherapy with temozolomide;
- Contraindications for performing magnetic resonance imaging (MRI), such as the use of implants or metallic prostheses;
- Pregnant women or women of childbearing age who refuse to undergo the beta-HCG test before treatment and contraception during the intervention.
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 Radiation Therapy60 Gy in 20 fractions of 3 Gy | Radiation | Single arm |
Primary outcome
Feasibility of accrual and planning
Time frame: From enrollment to the end of planning of the 10 patients at 5 months
Accrual of patients, timely and adequated planning of radiotherapy
Incidence of acute and late neurological toxicity
Time frame: Weekly evaluation during treatment and at 4, 12, 24, 36 weeks in the first year and every 6 months until 3 years after radiotherapy.
Incidence of headache, brain edema and brain radionecrosis will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
1 secondary outcome
Overall Survival and Progression Free Survival
Time frame: Start of radiotherapy to the date of event (death or progression of disease) up tp 3 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 25 Mar 2026.
- Background: PubMed 34150645Muller Bark J, Kulasinghe A, Hartel G, Leo P, Warkiani ME, Jeffree RL, Chua B, Day BW, Punyadeera C. Isolation of Circulating Tumour Cells in Patients With Glioblastoma Using Spiral Microfluidic Technology - A Pilot Study. Front Oncol. 2021 Jun 3;11:681130. doi: 10.3389/fonc.2021.681130. eCollection 2021.
- Background: PubMed 37452916Mallick S, Gupta S, Amariyil A, Kunhiparambath H, Laviraj MA, Sharma S, Sagiraju HKR, Julka PK, Sharma D, Rath GK. Hypo-fractionated accelerated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed glioblastoma: updated results from phase II HART-GBM trial. J Neurooncol. 2023 Aug;164(1):141-146. doi: 10.1007/s11060-023-04391-7. Epub 2023 Jul 15.
- Background: PubMed 23425509Jastaniyah N, Murtha A, Pervez N, Le D, Roa W, Patel S, Mackenzie M, Fulton D, Field C, Ghosh S, Fallone G, Abdulkarim B. Phase I study of hypofractionated intensity modulated radiation therapy with concurrent and adjuvant temozolomide in patients with glioblastoma multiforme. Radiat Oncol. 2013 Feb 20;8:38. doi: 10.1186/1748-717X-8-38.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial,
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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.
Douglas G Castro, MD PhD principal investigator
Hospital do Coracao
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiation Therapy in people with Glioblastoma (GBM), run by Hospital do Coracao.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Alexandre B Cavalcanti, MD PhD (55 11 3053 6611, abiasi@hcor.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of accrual and planning (time frame: From enrollment to the end of planning of the 10 patients at 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07492836, which also lists 3 linked publications.
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 25 Mar 2026.