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TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM

NCT03780569 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-20

No results posted yet for this study

Summary

The study is a prospective, single arm open label study, designed to test the to evaluate the tolerability and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to Radiotherapy/Temozolomide followed by Temozolomide. The device is a portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Conditions

Interventions

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.

Sponsors & Collaborators

  • NovoCure Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Israel

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03780569 on ClinicalTrials.gov