Titre officiel
EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumour Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma
Sommaire:
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.
Description de l'essai
Optune®
is a medical device that has been approved for the treatment of
recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug
Administration (FDA) in the United States. Optune® has obtained a CE
mark in Europe for recurrent and newly diagnosed GBM.
The current standard of
care for GBM includes the addition of Optune® to maintenance
temozolomide (TMZ), following the completion of radiation therapy (RT).
The purpose of the
current study is to test if the earlier introduction of Optune®, at the
time of radiation therapy (which is given together with temozolomide),
improves clinical outcomes compared to the standard of care.
The study will randomize 950 subjects equally to one of two treatment arms:
- Treatment arm I: Patients receive
TTFields at 200 kHz to the brain using the Optune® System together with
RT and TMZ, followed by maintenance TMZ concomitant with the Optune®
treatment.
- Treatment arm II: Patients receive RT
and TMZ alone, followed by maintenance TMZ concomitant with TTFields at
200 kHz to the brain using the Optune®.
All patients are to
receive standard RT and TMZ treatment followed by maintenance TMZ
chemotherapy and Optune® according to the current standard of care
regimen.
Optune® will continue
until second disease progression per RANO Criteria or 24 months (the
earlier of the two) unless any of the treatment discontinuation
conditions described under criteria for patient withdrawal or
termination are met.
After surgery or biopsy,
subjects that would like to participate will be required to submit
samples of their tumour to a lab for testing. The results of this test
will be used for randomization into the trial.
If the subject is
assigned to the treatment group that will start Optune® therapy during
radiation therapy, Optune® therapy will begin within 7 days of enrolling
in the study and no later than the first day of RT and TMZ treatment.
After the initial visit,
subjects will continue treatment at home, while pursuing normal daily
routines. Subjects are required to use the device for at least 18 hours a
day. Short breaks in treatment for personal hygiene and other personal
needs is allowed. Total usage time will be recorded and provided to the
sponsor.
Subjects will be
required to return to the clinic every 4 weeks until study participation
ends. Once every 8 weeks until the tumour potentially returns twice,
subjects will have a contrast MRI of the head and neurological exam
performed for the first 6 months of the study and then at least every
three months until a total time period of 24 months.Once every 12 weeks
until second disease progression, subjects will also fill out a quality
of life questionnaire.
After the second time
the tumour returns, subjects will return to the clinic for one final
visit approximately 30 days after the last treatment with Optune®.
After discontinuing
Optune® subjects will be contacted once per month by telephone to answer
basic questions about their health status.
Voir cet essai sur ClinicalTrials.gov
