Electric fields + chemo + radiation: a new attack on brain cancer?
NCT ID NCT04474353
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of tumor treating fields (a device that creates electric fields to disrupt cancer growth), stereotactic radiosurgery (precise radiation), and temozolomide chemotherapy in 12 adults with newly diagnosed glioblastoma. The main goal was to see if the combination is safe and to identify any severe side effects. The study is complete, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tumor treating fields (TTFields) device, temozolomide chemotherapy, and stereotactic radiosurgery
- What this could lead to
- If successful, this combination could offer a new way to control glioblastoma, potentially extending survival with manageable side effects.
- What could go wrong
- This is a very early phase 1 trial with only 12 people, so it's mainly checking safety, not effectiveness. The treatment may not work better than standard care and could cause serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
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May 2021
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * A maximum tumor target diameter of less than 5 cm on the post operative MRI used for SRS planning (a 5 mm margin is added in the radiotherapy planning process, yielding a maximum diameter of the planning target volume (PTV) of less than 6 cm). If the maximum diameter is greater than 5 cm, the subject is still eligible if the PTV is less than 113 cm3 which is the volume of a 6 cm diameter sphere. * 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) * Ability to tolerate MRI * Karnofsky Performance Scale (KPS) ≥ 60 * Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document. 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. * Subjects receiving the following medications at the time of combined TTFields and SRS: * Pharmacotherapy for tuberculosis or HIV as these medications are known to interact with temozolomide * Other chemotherapy, other investigational agents, or biologic agents for the treatment of cancer including antibodies (eg, bevacizumab, trastuzumab, pertuzumab), small molecules, or any investigational agent(s). * Pregnant or nursing females will be excluded from the study * History of inability to tolerate MRI
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University
Stanford, California, 94304, United States
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Other studies related to the condition(s) this trial covers.
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