Optune + Radiation & Chemotherapy for Brain Cancer

(EF-32 Trial)

Recruiting at161 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NovoCure GmbH

No Placebo Group

Trial Summary

What is the purpose of this trial?

To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

Research Team

Eligibility Criteria

This trial is for adults diagnosed with Glioblastoma who've had surgery and are planning to start radiation therapy with temozolomide within 8 weeks. They should have a life expectancy of at least 3 months, be able to use effective birth control, and have a Karnofsky performance status ≥ 70. Exclusions include pregnancy, significant liver or kidney issues, psychiatric conditions affecting study compliance, certain implanted devices, increased intracranial pressure, legal institutionalization, specific allergies or previous treatments.

Inclusion Criteria

I am starting radiation and TMZ treatment within 8 weeks after surgery.

I am scheduled for specific brain cancer treatments including radiation, chemotherapy, and TTFields.

I am able to care for myself but may not be able to do active work.

Exclusion Criteria

My kidney function is normal; my creatinine is not above 1.7 mg/dL.

I do not have severe side effects from treatment, except for hair loss or nausea.

I have had radiation treatment for brain cancer.

Treatment Details

Interventions

• Optune® (Device)

Trial Overview The trial tests the safety and effectiveness of Optune® used together with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients versus RT and TMZ alone. After RT treatment ends, participants will continue using Optune® along with maintenance doses of TMZ.

Participant Groups

Group I: Optune® + RT + TMZ for 6 weeks Experimental Treatment 1 Intervention

Optune® + RT + TMZ for 6 weeks, followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.

Group II: RT +TMZ for 6 weeks Active Control 1 Intervention

RT +TMZ for 6 weeks followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression.

Who Is Running the Clinical Trial?

NovoCure GmbH

Lead Sponsor

Trials

16

Recruited

3,700+

NovoCure Ltd.

Lead Sponsor

Trials

64

Recruited

6,100+

Ashley Cordova

NovoCure Ltd.

Chief Executive Officer

Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel

Uri Weinberg

NovoCure Ltd.

Chief Medical Officer since 2020

MD from an unspecified institution