Loading clinical trials...

Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma

Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma

NCT03506139•John M. Buatti

View on ClinicalTrials.gov

Summary

This clinical trial increases radiation to areas of the brain considered to be at risk for cancer. The at-risk areas are identified by a biological MRI scan. The study will look at side effects of the radiation and overall survival.

Detailed Description

This study evaluates if increasing radiation dose to at-risk areas impacts overall survival without causing a decrease in quality of life or an increase in radiation side effects. Standard radiation dose for glioblastoma (GBM) is 60 Gray in 30 fractions, with patients receiving 1 fraction per day, Monday through Friday. This trial will use a total of 75 Gray in 30 fractions, with participants receiving 1 fraction per day, Monday through Friday. Participants will still receive the standard chemotherapy (temozolomide) at the standard dose (75 mg/m2, once daily, 7 days a week). This study also uses a different imaging technique to identify the tumor target and the tissues at risk. Normal imaging techniques will be used to define the standard target volume and will receive the standard radiation dose (60 Gray). A special MRI sequence will identify at risk areas based on diffusion and perfusion abnormalities. This area will receive the higher radiation dose (75 Gray). Participants will also be asked to complete quality of life questionnaires and neurocognitive evaluations at specific time points. This is to identify any side effects from the higher radiation dose. Preliminary work done at University of Michigan suggests a lack of side effects from the higher dose of radiation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to understand and willingness to provide informed consent
•Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma.
•Patients must be 18 years of age or older.≥
•Karnofsky performance status ≥ 70
•Minimal life expectancy of 12 weeks.
•Maximal contiguous volume of tumor based on high b-value diffusion MRI and perfusion MRI \< 1/3 volume of brain
•Patients must be treated within 6 weeks of most recent resection
•Within 21 days of radiation fraction 1, the following blood test parameters must be met:
•Hemoglobin ≥ 10 g/dL (transfusion is acceptable)
•absolute neutrophils ≥ 1500/mm3
+4 more criteria

Exclusion Criteria

•Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
•Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is \>3 years.
•Evidence of CSF dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination).
•Multifocal disease (\>1 lobe of involvement) of discontiguous, contrast enhancing disease as seen on conventional MRI
•Evidence of severe concurrent disease requiring treatment
•Known active malignancy as determined by treating medical and radiation oncologist
•Patients unable to undergo MRI exams
•Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring inpatient hospitalization or delay treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise subject safety.
•Pregnant women are excluded from this study because ionizing radiation is a known teratogen, and temozolomide is a Class D agent with the potential for teratogenic or abortifacient effects.
+2 more criteria

Locations (1)

University of Iowa Department of Radiation Oncology

Iowa City, Iowa, United States

Key Dates

Start Date

May 15, 2019

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2026

Last Updated

September 9, 2020

Conditions

GlioblastomaGlioblastoma Multiforme

Interventions

External beam radiation therapy

RADIATION

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

NCT00083512

Glioblastoma Multiforme

View study

RECRUITINGPHASE1

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

View study

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: September 9, 2020Data 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.

View ClinicalTrials.gov Terms and Conditions

Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma

Inclusion Criteria

Exclusion Criteria

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

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

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