Suspended

Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma

What is being tested

Hypofractionated radiation therapy

Radiation

Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

From 18 to 70 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: June 2017

See protocol details

Summary

Principal SponsorInstituto do Cancer do Estado de São Paulo

Study ContactGustavo N Marta, PhD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 5, 2017

Actual date on which the first participant was enrolled.

Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.

Official TitleHypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma

NCT03212235

Principal SponsorInstituto do Cancer do Estado de São Paulo

Study ContactGustavo N Marta, PhD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

58 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

2 inclusion criteria required to participate

Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.

WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.

6 exclusion criteria prevent from participating

Prior diagnosis of cancer, unless disease free for > 3 years

Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).

Specific severe, active co-morbidities

Tumor located in the brainstem

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP

São Paulo, BrazilOpen Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP in Google Maps

SuspendedOne Study Center