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

Hospital do Coracao

Status

Not yet enrolling

Conditions

Glioblastoma (GBM)

Treatments

Radiation: Hypofractionated Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07492836

95122526.0.0000.0060

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.