First Patient Enrolled in RTOG Trial of Optune® together with Bevacizumab for Patients with Bevacizumab-Refractory Recurrent Glioblastoma
The RTOG 3503 phase 2 pilot trial is the first consortium study to test treatment with Optune
ST. HELIER, Jersey–(BUSINESS WIRE)–
Optune is an
“The results of this trial will provide additional information to the brain tumor research community on the safety and effectiveness of using Optune in combination with bevacizumab in patients with bevacizumab-refractory recurrent GBM,” said Dr.
The RTOG Foundation Study RTOG 3503 is planned to include 85 patients at 20 institutions in
“This is the first consortium study of TTFields, demonstrating the continued and mounting interest in Optune from the scientific community,” said Dr.
“For 40 years, RTOG has conducted studies designed to improve the survival and quality of life of cancer patients,” said Dr.
For more information on the trial designs, visit clinicaltrials.gov and reference NCT02743078. Treatment with TTFields is not approved in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM by the
Headquartered in Jersey,
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Important Safety Information
Contraindications: Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions: Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by
Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.
The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.
The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.
The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and trained personnel.
Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.
Please visit Optune.com/Safety for Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
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