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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHospital do Coracao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Initial histological diagnosis of glioblastoma

Age > 18 and < 70 years;

Karnofsky Performance Status > 70%;

Patient consent to participate in the study.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypofractionated Radiation Therapy

    Radiation

    60 Gy in 20 fractions of 3 Gy

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of accrual and planning

Accrual of patients, timely and adequated planning of radiotherapy

Time frame
From enrollment to the end of planning of the 10 patients at 5 months
2

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.

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.

Secondary outcomes

1

Overall Survival and Progression Free Survival

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

Time frame
Start of radiotherapy to the date of event (death or progression of disease) up tp 3 years

Other outcomes

1

Correlative science

Evaluation of circulating tumor cells in the blood

Time frame
Before and 4 to 6 weeks after radiotherapy

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: