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Trial of Hypofractionated Radiation Therapy for Glioblastoma

A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma

NCT02206230•AHS Cancer Control Alberta

View on ClinicalTrials.gov

Summary

This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma

Detailed Description

Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 - 70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield survival non-inferior to conventional fractioned RT, allowing significant abbreviation of the length of the radiation course required for these patients with limited survival. The importance of hypofractionation is, therefore, not in improving survival, but rather to shorten RT duration to improve patient comfort and convenience. This approach is pertinent given the limited life expectancy of glioblastoma and has been used in patients with prolonged survival including breast and prostate cancers.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Newly-diagnosed, histologically proven, intracranial glioblastoma or gliosarcoma treated with maximal safe resection, which may be biopsy alone if resection is not possible.
•2. History and physical examination, including neurological examination, within 14 days prior to randomization.
•3. Age between 18 and 70 years, inclusive.
•4. ECOG performance score 0-2.
•5. Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization (Stupp et al.).
•6. Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below: (Stupp et al.)
•1. ANC ≥ 1.5 x 10\^9/L
•2. Platelets ≥ 100 x 10\^9/L
•3. Serum creatinine ≤ 1.5 times ULN
•4. Total serum bilirubin ≤ 1.5 times ULN
+4 more criteria

Exclusion Criteria

•1. Recurrent or multifocal malignant gliomas. Multicentric gliomas, defined as multiple, discrete areas of enhancement on T1 weighted MRI sequences with contrast all contained within one connected region of abnormality on T2 weighted/FLAIR MRI sequences, are allowed to enroll on this study.
•2. Prior invasive malignancy (except for non-melanomatous skin cancer) unless expected survival from prior malignancy is ≥ 5 years.
•3. Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide
•4. Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.
•5. Severe, active co-morbidity, defined as follows:
•1. Unstable angina and/or congestive heart failure requiring hospitalization
•2. Transmural myocardial infarction within the last 6 months
•3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration
•4. Any severe, active co-morbidity precluding delivery of temozolomide.
•6. Women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
+1 more criteria

Locations (1)

Cross Cancer Institute

Edmonton, Alberta, Canada

Key Dates

Start Date

September 25, 2014

Primary Completion Date

February 14, 2023

Completion Date

February 14, 2023

Last Updated

January 31, 2024

Enrollment

133

ACTUAL participants

Conditions

Glioblastoma

Interventions

Hypofractionated radiation therapy

RADIATION

Standard radiation therapy

RADIATION

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Hypofractionated Radiation Therapy for Glioblastoma

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Targeted Pediatric High-Grade Glioma Therapy

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma