Optune + Radiation & Chemotherapy for Brain Cancer

(EF-32 Trial)

Recruiting at 169 trial locations

Overseen By Doron Manzur, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NovoCure GmbH

Must be taking: Temozolomide

Disqualifiers: Pregnancy, Psychiatric conditions, Liver impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

981 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding Optune®, a device that uses electric fields to disrupt cancer cell division, to standard radiation and chemotherapy is more effective for treating newly diagnosed glioblastoma (GBM) than radiation and chemotherapy alone. The goal is to determine if this combination can better control the cancer. Participants will receive either radiation and chemotherapy alone or with Optune® to compare outcomes. This trial suits those diagnosed with GBM who have already undergone surgery, if necessary. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future GBM treatments.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have a stable or decreasing dose of corticosteroids for the last 7 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Optune®, a device using Tumor Treating Fields (TTFields), is safe. Studies with both children and adults with brain tumors found Optune® to be safe, with no unexpected problems. The FDA has approved it for treating glioblastoma, a type of brain cancer, indicating it has been tested for safety in people. Additionally, ongoing global safety checks for adults with glioblastoma have not identified any new safety issues. This device is noninvasive and wearable, allowing for continuous treatment without surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike traditional treatments for brain cancer, which typically involve surgery, radiation, and chemotherapy, Optune offers a unique approach by using Tumor Treating Fields (TTFields). These are low-intensity, alternating electric fields that disrupt cancer cell division, directly targeting the tumor without affecting healthy cells. Researchers are excited about Optune because it provides a non-invasive and continuous treatment option, potentially improving patient outcomes when used alongside standard therapies like radiation and temozolomide. This novel mechanism of action sets Optune apart, offering a promising new avenue for treating aggressive brain cancers.

What evidence suggests that Optune® combined with radiation and chemotherapy could be effective for brain cancer?

In this trial, participants will receive different treatment combinations involving Optune®. Research has shown that Optune®, when combined with standard treatments like radiation and the drug temozolomide, can significantly benefit patients with glioblastoma (GBM), a type of brain cancer. Studies have demonstrated that Optune® increased the time during which the cancer did not worsen from 4.0 months to 7.1 months and extended overall survival from 16.0 months to 20.9 months. One study found that patients who used Optune® more than 90% of the time lived a median of 24.9 months and had better long-term survival rates. These findings suggest that Optune® can effectively complement traditional GBM treatments. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Optune® with RT and TMZ for 6 weeks, followed by maintenance TMZ and Optune® until second disease progression

6 weeks

Initial visit, then home treatment with regular clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with monthly phone calls to assess health status

5 years

Monthly phone calls

Open-label extension

Participants continue Optune® and TMZ treatment until second disease progression

Until second disease progression

What Are the Treatments Tested in This Trial?

Interventions

• Optune®

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

A review of 77 studies involving 6384 patients found that stereotactic radiosurgery (SRS) combined with systemic therapies (like chemotherapy and immunotherapy) is safe, showing no significant increase in skin toxicities, bleeding, or radiation necrosis.

The median SRS dose was 20 Gy, and the findings support the continuation of systemic treatments alongside SRS for patients with brain metastases, indicating that this combination does not adversely affect patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of radiosurgery concurrent with systemic therapy (chemotherapy, targeted therapy, and/or immunotherapy) in brain metastases: a systematic review. Borius, PY., Régis, J., Carpentier, A., et al.[2021]

Cerebral radiation necrosis (RN) is a serious complication that can occur after brain radiotherapy, with its incidence influenced by factors like total dose and treatment modality.

The case presented highlights that concurrent immunotherapy, specifically immune checkpoint inhibitors, may increase the risk of developing RN even when radiotherapy is applied to non-brain areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Symptomatic Cerebral Radiation Necrosis for an Extra-Cranial Neoplasm from Conventional Radiotherapy With Concurrent Immunotherapy. Gutta, R., Balanchivadze, N., Wang, D.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10695547/

Efficacy of tumour-treating fields therapy in recurrent ... This review synthesizes the current evidence surrounding the efficacy of TTFields Therapy in the context of recurrent Glioblastoma.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825003686

Tumor treating fields utilization and efficacy for ... Tumor treating fields (TTF) improved progression-free survival (7.1 versus 4.0 months) and overall survival (20.9 months versus 16.0 months) in a phase III ...

3. academic.oup.com academic.oup.com/oncolo/article/30/2/oyae227/7821273

Recent advances in Tumor Treating Fields (TTFields) therapy ... For the latter, results from a 30-patient study showed a median PFS of 9.3 months, median OS of 15.8 months, and 1-year survival of 66% ( ...

4. optunegio.com optunegio.com/recently-diagnosed-gbm/results-optune

Optune Gio®'s results as part of GBM treatments A large, randomized clinical trial showed that glioblastoma (GBM) treatments using Optune Gio® result in better survival rates at 2 years and at 5 years.

5. novocure.com novocure.com/patients-who-used-optune-more-than-90-percent-of-the-time-had-the-greatest-chance-of-survival-in-novocures-ef-14-trial-a-median-survival-of-24-9-months-from-randomization-and-a-five-ye

Patients Who Used Optune® More Than 90 Percent of the ... Patients who used Optune more than 90 percent of the time had the greatest chance of survival: a median survival of 24.9 months from randomization and a five- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9443515/

Safety of Tumor Treating Fields (TTFields) therapy in pediatric ... The real-world data reported here demonstrate that TTFields therapy has a favorable safety profile for pediatric patients with brain tumors, with no new safety ...

7. optunegiohcp.com optunegiohcp.com/

Optune Gio® | FDA-approved glioblastoma (GBM) treatment Optune Gio is a wearable, noninvasive device using TTFields for continuous glioblastoma treatment, empowering GBM patient care.

8. link.springer.com link.springer.com/article/10.1007/s11060-024-04682-7

Global post‑marketing safety surveillance of Tumor ... Safety profile of Tumor Treating Fields in adult glioblastoma patients with implanted non-programmable shunts, programmable shunts, and ...

9. thebraintumourcharity.org thebraintumourcharity.org/brain-tumour-diagnosis-treatment/treating-brain-tumours/emerging-treatments/ttf-tumour-treating-fields/

Tumour Treating Fields (TTF) or Optune® The Optune device is FDA (Food & Drug Administration) approved in the USA; and CE marked in the European Union. This means it has proved itself to be “safe and ...

10. novocuretrials.com novocuretrials.com/cancer-clinical-trials/glioblastoma-clinical-trial-trident

TRIDENT - Glioblastoma Clinical Trial This clinical trial is evaluating the safety and efficacy of Tumor Treating Fields (TTFields) delivered by the Optune treatment paired with radiation therapy ...