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Clinical Trial NCT07492836 (HipoGBM) for Glioblastoma (GBM) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Hypofractionated Radiotherapy Plus Temozolamide in Patients Younger Than 70 Years With Glioblastoma (HipoGBM) 10

Not yet recruiting
Clinical Trial NCT07492836 (HipoGBM) is an interventional study for Glioblastoma (GBM) and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 10 participants. Led by Hospital do Coracao, this study is expected to complete by 1 April 2029. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 tumo...Show More
Official Title

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

Conditions
Glioblastoma (GBM)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • HipoGBM
  • 95122526.0.0000.0060
NCT ID Number
NCT07492836
Start Date (Actual)
2026-04
Last Update Posted
2026-03-25
Completion Date (Estimated)
2029-04
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Radiotherapy
Temozolamide
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSingle arm
Hypofractonated Radiotherapy
Hypofractionated Radiation Therapy
60 Gy in 20 fractions of 3 Gy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Feasibility of accrual and planning
Accrual of patients, timely and adequated planning of radiotherapy
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.
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall Survival and Progression Free Survival
Death from any cause and disease progression during treatment and follow-up time
Start of radiotherapy to the date of event (death or progression of disease) up tp 3 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Initial histological diagnosis of glioblastoma
  • Age > 18 and < 70 years;
  • Karnofsky Performance Status > 70%;
  • Patient consent to participate in the study.

  • 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.
Hospital do Coracao logoHospital do Coracao
Study Central Contact
Contact: Alexandre B Cavalcanti, MD PhD, 55 11 3053 6611, [email protected]
Contact: Karina L Negrelli, VMD, 55 11 3053 6611, [email protected]
No location data.