Hypofractionated Radiotherapy Plus Temozolamide in Patients Younger Than 70 Years With Glioblastoma

Prospective, Pilot Study to Evaluate Hypofractionated Radiotherapy Associated With Temozolomide in Patients Aged 18 to 70 Years With Glioblastoma (HypoGBM)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07492836

Acronym

HipoGBM

Enrollment

Registered

2026-03-25

Start date

2026-04-01

Completion date

2029-04-01

Last updated

2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma (GBM)

Keywords

Radiotherapy, Temozolamide

Brief 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.

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.

Interventions

RADIATIONHypofractionated Radiation Therapy

60 Gy in 20 fractions of 3 Gy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Hypofractonated Radiotherapy with 60 Fy in 20 fractions of 3 Gy

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Initial histological diagnosis of glioblastoma * Age \> 18 and \< 70 years; * Karnofsky Performance Status \> 70%; * Patient consent to participate in the study.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of accrual and planning	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	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.

Secondary

Measure	Time frame	Description
Overall Survival and Progression Free Survival	Start of radiotherapy to the date of event (death or progression of disease) up tp 3 years	Death from any cause and disease progression during treatment and follow-up time

Contacts

CONTACTAlexandre B Cavalcanti, MD PhD

abiasi@hcor.com.br55 11 3053 6611

CONTACTKarina L Negrelli, VMD

knegrelli@hcor.com.br55 11 3053 6611

PRINCIPAL_INVESTIGATORDouglas G Castro, MD PhD

Hospital do Coracao

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026