TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM
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ClinicalTrials.gov Identifier: NCT03780569 |
Recruitment Status : Unknown
Verified December 2018 by NovoCure Ltd..
Recruitment status was: Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : December 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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Glioblastoma Multiforme | Device: NovoTTF-200A Radiation: Radiotherapy Drug: Temozolomide | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Trial of NovoTTF-200A Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM |
Actual Study Start Date : | April 27, 2017 |
Estimated Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
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Experimental: NovoTTF-200A/Radiotherapy/Temozolomide
Patients will receive multiple 1 month courses of continuous NovoTTF-200A treatment together with standard Radiotherapy/Temozolomide followed by maintenance Temozolomide.
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Device: NovoTTF-200A
Patients receive continuous TTFields treatment using the NovoTTF-200A device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the scalp. The treatment enables the patient to maintain regular daily routine. Radiation: Radiotherapy 60Gy given in 30 2Gy fractions concomitant to temozolomide Drug: Temozolomide Temozolomide(TMZ) will be administered at 75 mg/m^2 concomitant to radiotherapy(RT) and NovoTTF-200A. Maintenance treatment is to begin about 4 weeks after the end of TMZ/RT/NovoTTF-200A. TMZ is administered at the conventional dosing regimen for 5 days, every 28 days (i.e. 5 days of therapy, 23 days of rest). Cycle 1 is to be given at a dose of 150 mg/m^2 p.o. daily x 5 days, dose to be escalated to 200 mg/m^2 in the absence of toxicity. |
- Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A. [ Time Frame: 2 years ]The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.
- Progression free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 years ]
- Adverse events, severity and frequency [ Time Frame: 2 years ]Safety of NovoTTF-200A treatment based on the incidence and severity of adverse events and toxicities.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Supratentorial tumor location
- Age ≥ 18 years
- Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)
- Planned standard adjuvant chemoradiotherapy of approx. 60 Gy of Radiotherapy (RT), or biologically equivalent dose, according to local practice, and concomitant Temozolomide (TMZ) chemotherapy (75mg/m^2 daily). Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be considered an exclusion.
- Planned treatment with adjuvant/maintenance TMZ (150-200 mg/m^2 daily x 5 d, q28 days)
- Karnofsky performance status ≥ 70
- Life expectancy ≥ 3 months
- Participants of childbearing age must use effective contraception.
- All patients must sign written informed consent.
- NovoTTF-200A treatment start date at least 2 weeks out from brain surgery.
- NovoTTF-200A treatment start prior to or at the beginning of RT/TMZ
- Stable or decreasing dose of corticosteroids for the last 7 days prior to enrollment, if applicable.
Exclusion Criteria:
- Participation in another clinical treatment trial
- Pregnancy or breast feeding
- Significant co-morbidities at baseline which would preclude TMZ treatment
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- Infra-tentorial tumor location
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
- Known allergies to medical adhesives or gel

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780569
Israel | |
Tel Aviv Sourasky Medical Center | |
Tel Aviv, Israel |
Responsible Party: | NovoCure Ltd. |
ClinicalTrials.gov Identifier: | NCT03780569 |
Other Study ID Numbers: |
ICH-1 |
First Posted: | December 19, 2018 Key Record Dates |
Last Update Posted: | December 20, 2018 |
Last Verified: | December 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
GBM TTFields Tumor Treating Fields Glioblastoma Glioblastoma Multiforme |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |