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

March 19, 2026 updated by: Hospital do Coracao

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexandre B Cavalcanti, MD PhD
  • Phone Number: 55 11 3053 6611
  • Email: abiasi@hcor.com.br

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Hypofractonated Radiotherapy
Radiation: Hypofractionated Radiation Therapy
60 Gy in 20 fractions of 3 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of planning of the 10 patients at 5 months
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.
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 Measure
Measure Description
Time Frame
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
Start of radiotherapy to the date of event (death or progression of disease) up tp 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlative science
Time Frame: Before and 4 to 6 weeks after radiotherapy
Evaluation of circulating tumor cells in the blood
Before and 4 to 6 weeks after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Coracao

Investigators

  • Principal Investigator: Douglas G Castro, MD PhD, Hospital do Coracao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95122526.0.0000.0060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected throughout the trial,

IPD Sharing Time Frame

Beginning 6 months after publication with no end date

IPD Sharing Access Criteria

A proposal that describes planned analyses must be submitted by a researcher with a history of publishing on the topic

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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