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Device

Optune + Radiation & Chemotherapy for Brain Cancer (EF-32 Trial)

N/A

Waitlist Available

Research Sponsored by NovoCure GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status ≥ 70

Histologically confirmed diagnosis of GBM according to WHO classification criteria

Must not have

Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l)

Admitted to an institution by administrative or court order

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for brain cancer that combines Optune with radiation and chemotherapy. The goal is to see if this new combination is more effective and has fewer side effects than current treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Optune®, when used alongside RT and TMZ may cause skin irritation beneath device electrodes; headaches; malaise; muscle twitching; falls related to carrying the device if not managed properly. Temozolomide can lead to nausea/vomiting, fatigue, hair loss (alopecia), constipation/diarrhea & blood-related side effects like low platelets/neutrophils.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My diagnosis is glioblastoma multiforme (GBM) as per WHO standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I was admitted to a facility by court or administrative order.

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I have not received any cancer treatment before joining this trial.

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I have had radiation treatment for brain cancer.

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

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My liver tests are more than three times the normal limit.

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I have symptoms of high pressure in my brain.

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My cancer has spread to the lower part of my brain or its lining.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

1- and 2-year survival rates

Dependence of overall survival on TTFields dose at the tumor

Next progression-free survival (PFS2)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Optune® + RT + TMZ for 6 weeksExperimental Treatment1 Intervention

Optune® + RT + TMZ for 6 weeks, followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression or 24 months.

Group II: RT +TMZ for 6 weeksActive Control1 Intervention

RT +TMZ for 6 weeks followed by Optune® + TMZ until the tumor progresses. Optune treatment is maintained until second disease progression or 24 months.

0 / 10Eligibility criteria met