← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

EF-32 Trial 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.Check my eligibility

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.See study design

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.

EF-32 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

EF-32 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

1- and 2-year survival rates

Dependence of overall survival on TTFields dose at the tumor

Next progression-free survival (PFS2)

+7 more

EF-32 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NovoCure GmbHLead Sponsor

11 Previous Clinical Trials

1,789 Total Patients Enrolled

2 Trials studying Glioblastoma

110 Patients Enrolled for Glioblastoma

Media Library

Optune® (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04471844 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this clinical research study?

"This medical trial requires 950 suitable patients to sign up. Participants can register at two locations, the University of Mississippi Medical Center in Jackson and BC Cancer Agency Vancouver Centre in Vancouver."

Answered by AI

Is this investigation currently open to new participants?

"According to clinicaltrials.gov , this trial is actively recruiting with the initial posting of the study being on December 8th 2020, and most recent update occurring 12/1/2022."

Answered by AI

How many centers are overseeing this trial?

"This clinical trial is conducted in a multitude of locations, but the primary sites are: University of Mississippi Medical Center (Jackson, Mississippi), BC Cancer Agency Vancouver Centre (Vancouver, British Columbia), and Allegheny Health Network Cancer Institute (Pittsburgh Pennsylvania). Additionally there are 95 additional research centres."

Answered by AI