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NCT Number: NCT07492836

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypofractionated Radiation Therapy

Radiation

60 Gy in 20 fractions of 3 Gy

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

    Death from any cause and disease progression during treatment and follow-up time

Other outcomes

  1. Correlative science

    Time frame: Before and 4 to 6 weeks after radiotherapy

    Evaluation of circulating tumor cells in the blood

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre B Cavalcanti, MD PhD

CONTACT

[email protected]

55 11 3053 6611

Karina L Negrelli, VMD

CONTACT

[email protected]

55 11 3053 6611

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

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

Acronym: HipoGBM

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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