Hypofractionated Radiation Therapy
Radiation60 Gy in 20 fractions of 3 Gy
NCT Number: NCT07492836
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60 Gy in 20 fractions of 3 Gy
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
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.
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
Time frame: Before and 4 to 6 weeks after radiotherapy
Evaluation of circulating tumor cells in the blood
Contact information is provided by the study sponsor or research team.
Alexandre B Cavalcanti, MD PhD
CONTACT
Karina L Negrelli, VMD
CONTACT
Hospital do Coracao
Other
Prospective, Pilot Study to Evaluate Hypofractionated Radiotherapy Associated With Temozolomide in Patients Aged 18 to 70 Years With Glioblastoma (HypoGBM)
Acronym: HipoGBM
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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