Optune + Radiation & Chemotherapy for Brain Cancer

(EF-32 Trial)

Recruiting at 161 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

982 Participants Needed

What You Need to Know Before You Apply

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.

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 the combination of Optune, radiation, and chemotherapy generally safe for humans?

Research indicates that combining radiation with systemic therapies like chemotherapy and immunotherapy is generally safe, with no significant increase in severe side effects such as skin toxicity or radiation necrosis. However, there is a risk of side effects like ototoxicity (hearing damage) and cerebral radiation necrosis, especially when combined with certain drugs. ^{1 2 3 4 5}

How is the Optune treatment for brain cancer different from other treatments?

Optune is unique because it uses electric fields to disrupt cancer cell division, which is different from traditional treatments like chemotherapy and radiation that use drugs or high-energy rays to kill cancer cells. This approach is non-invasive and can be used alongside other treatments to potentially improve outcomes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Optune® when used with radiation and chemotherapy for brain cancer?

Research shows that combining chemotherapy with radiation therapy can improve survival rates for patients with brain tumors like gliomas and glioblastoma multiforme. Chemotherapy drugs such as BCNU, when used with radiation, have been effective in increasing survival, suggesting that combining treatments can be beneficial. ^{8 10 11 12 13}

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. United States pubmed.ncbi.nlm.nih.gov

Does chemotherapy benefit the patient with a central nervous system glioma? [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme: North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 Trials. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Estimation of an optimal chemotherapy utilisation rate for primary malignant brain tumours: an evidence-based benchmark for cancer care. [2010]

4. France pubmed.ncbi.nlm.nih.gov

Basis and results of chemotherapeutic treatment of gliomas. [2009]

5. Greece pubmed.ncbi.nlm.nih.gov

Multi-drug versus single agent chemotherapy for high grade astrocytoma; results of a meta-analysis. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Ototoxicity in children with malignant brain tumors treated with the "8 in 1" chemotherapy protocol. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of radiosurgery concurrent with systemic therapy (chemotherapy, targeted therapy, and/or immunotherapy) in brain metastases: a systematic review. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Radiation in Combination With Targeted Agents and Immunotherapies for Pediatric Central Nervous System Tumors - Progress, Opportunities, and Challenges. [2021]

9. Poland pubmed.ncbi.nlm.nih.gov

[Analysis of selected undesirable effects of cytostatic drugs in treatment of the central nervous system tumours in children. Preliminary report]. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

A Case of Symptomatic Cerebral Radiation Necrosis for an Extra-Cranial Neoplasm from Conventional Radiotherapy With Concurrent Immunotherapy. [2021]

11. Japan pubmed.ncbi.nlm.nih.gov

[Chemoradiation for malignant brain tumors]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Combined cyclotron fast-neutron and BCNU therapy in a rat brain-tumor model. [2013]

13. Italy pubmed.ncbi.nlm.nih.gov

Therapeutic strategy for central nervous system tumors: present status, criticism and potential. [2017]