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

NCT ID: NCT04474353

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2025-09-02

Brief 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

Conditions

Glioblastoma; Newly Diagnosed Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Novo-TTF

Day 1: Subjects will wear the Optune (TTFields device) for ≥ 18 hours/day. They will take off the device when receiving stereotactic radiosurgery and brain MRI scans.

Days 1 to 8: Subjects will take oral temozolomide 75 mg/m2/day Days 2 to 8: Subjects will receive stereotactic radiosurgery (total of 35 Gy) divided equally over 5 days

• After the interventional treatment, subjects will receive standard of care adjuvant chemotherapy and routine surveillance brain MRI scans.

Group Type: EXPERIMENTAL

Optune

Intervention Type: DEVICE

Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure

Gadolinium

Intervention Type: DRUG

Gadolinium contrast medium

Temozolomide

Intervention Type: DRUG

Chemotherapy agent

Stereotactic radiosurgery (SRS)

Intervention Type: RADIATION

Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2

Interventions

Optune

Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure

Intervention Type: DEVICE

Gadolinium

Gadolinium contrast medium

Intervention Type: DRUG

Temozolomide

Chemotherapy agent

Intervention Type: DRUG

Stereotactic radiosurgery (SRS)

Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2

Intervention Type: RADIATION

Other Intervention Names

Contrast agent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovoCure Ltd.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Scott Soltys

Professor of Radiation Oncology (Radiation Therapy)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott G Soltys

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

NCI-2021-06752

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-53582

Identifier Type: -

Identifier Source: org_study_id