NCT07492836

Brief Summary

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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
35mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

March 11, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 11, 2026

Last Update Submit

March 19, 2026

Conditions

Glioblastoma (GBM)

Keywords

RadiotherapyTemozolamide

Outcome Measures

Primary Outcomes (2)

  • Feasibility of accrual and planning

    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

    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 Outcomes (1)

  • Overall Survival and Progression Free Survival

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

Other Outcomes (1)

  • Correlative science

    Before and 4 to 6 weeks after radiotherapy

Study Arms (1)

Single arm

EXPERIMENTAL

Hypofractonated Radiotherapy

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation TherapyRADIATION

60 Gy in 20 fractions of 3 Gy

Single arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Initial histological diagnosis of glioblastoma
  • Age \> 18 and \< 70 years;
  • Karnofsky Performance Status \> 70%;
  • Patient consent to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Muller Bark J, Kulasinghe A, Hartel G, Leo P, Warkiani ME, Jeffree RL, Chua B, Day BW, Punyadeera C. Isolation of Circulating Tumour Cells in Patients With Glioblastoma Using Spiral Microfluidic Technology - A Pilot Study. Front Oncol. 2021 Jun 3;11:681130. doi: 10.3389/fonc.2021.681130. eCollection 2021.

    PMID: 34150645BACKGROUND

  • Mallick S, Gupta S, Amariyil A, Kunhiparambath H, Laviraj MA, Sharma S, Sagiraju HKR, Julka PK, Sharma D, Rath GK. Hypo-fractionated accelerated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed glioblastoma: updated results from phase II HART-GBM trial. J Neurooncol. 2023 Aug;164(1):141-146. doi: 10.1007/s11060-023-04391-7. Epub 2023 Jul 15.

    PMID: 37452916BACKGROUND

  • Jastaniyah N, Murtha A, Pervez N, Le D, Roa W, Patel S, Mackenzie M, Fulton D, Field C, Ghosh S, Fallone G, Abdulkarim B. Phase I study of hypofractionated intensity modulated radiation therapy with concurrent and adjuvant temozolomide in patients with glioblastoma multiforme. Radiat Oncol. 2013 Feb 20;8:38. doi: 10.1186/1748-717X-8-38.

    PMID: 23425509BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Douglas G Castro, MD PhD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre B Cavalcanti, MD PhD

CONTACT

55 11 3053 6611abiasi@hcor.com.br

Karina L Negrelli, VMD

CONTACT

55 11 3053 6611knegrelli@hcor.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Hypofractonated Radiotherapy with 60 Fy in 20 fractions of 3 Gy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 25, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2029

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial,

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 6 months after publication with no end date
Access Criteria
A proposal that describes planned analyses must be submitted by a researcher with a history of publishing on the topic