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Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma

A Phase 1 Study of Tumor Treating Fields With 5 Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma

NCT04474353•Stanford University

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) for newly diagnosed glioblastoma (GBM).

Detailed Description

Primary Objective: Determine the safety of Tumor Treating Fields (TTFields) started concurrently with 5 fraction stereotactic radiosurgery (SRS) and temozolomide for newly diagnosed glioblastoma. secondary objective: Efficacy for the combination of TTFields started concurrently with 5

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histopathologically proven newly diagnosed glioblastoma (GBM, WHO Grade IV) or molecular GBM of lower grade that will be treated as per glioblastoma (defined as IDH wild type, 1p19q not co deleted)
•Age ≥ 18 years
•Adequate organ function (obtained within 14 days prior to Day 0) as evidenced by:
•* Absolute neutrophil count (ANC) ≥ 1.5 × 109/L without myeloid growth factor support for 7 days preceding the lab assessment
•* Hemoglobin (Hgb) ≥ 9 g/dL (90 g/L); \< 9 g/dL (\< 90 g/L) is acceptable if hemoglobin is corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to Day 0
•* Platelet count ≥ 100 × 109/L without blood transfusions for 7 days preceding the lab assessment
•* Bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with documented history of Gilbert's disease
•* Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 × ULN
•* Alkaline phosphatase (AP) ≤ 3 × ULN
•* Women of childbearing potential (WCBP): negative serum pregnancy test (this test is required of all women unless post menopausal, defined as 12 consecutive months since last regular menses or surgically sterile)
+3 more criteria

Exclusion Criteria

•Previous chemotherapy or radiotherapy for glioma
•Concurrent use of experimental therapies
•Known allergy to adhesive tapes or other skin adhesives used in medical care
•Known underlying skin hypersensitivity or other condition of the scalp with potential toxicity per pre treatment dermatology evaluation
•Subjects with the following co morbid disease or incurrent illness:
•* Subjects with known cirrhosis diagnosed with Child Pugh Class A or higher liver disease.
•* Prior malignancy except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to first dose of investigational drug
•* Severe/uncontrolled inter current illness within the previous 28 days prior to first day of treatment
•* Subjects who have implantable devices that are contra indicated for use with TTFields
•* Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
+5 more criteria

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

May 21, 2021

Primary Completion Date

November 14, 2024

Completion Date

September 2, 2025

Last Updated

December 26, 2025

Enrollment

ACTUAL participants

Conditions

GlioblastomaNewly Diagnosed Glioblastoma

Interventions

Optune

DEVICE

Gadolinium

DRUG

Temozolomide

DRUG

Stereotactic radiosurgery (SRS)

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

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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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: December 26, 2025Data 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

Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma

Inclusion Criteria

Exclusion Criteria

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

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

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