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Hypofractionated Radiation Therapy for Glioblastoma

Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03212235
Enrollment
58
Registered
2017-07-11
Start date
2017-06-05
Completion date
2020-06-01
Last updated
2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Brief summary

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.

Interventions

RADIATIONHypofractionated radiation therapy

Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)

Sponsors

Instituto do Cancer do Estado de São Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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 * Presence of leptomeningeal carcinomatosis * Multicentric tumor

Design outcomes

Primary

MeasureTime frameDescription
Overall survival24 monthsFrom date of the start of treatment to date of death due to any cause.

Secondary

MeasureTime frameDescription
Progression-free survival24 monthsThe time between the start of treatment and tumor progression or death due to any cause.

Countries

Brazil

Contacts

Primary ContactGustavo N Marta, PhD
gustavo.marta@hc.fm.usp.br551138934538

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026