Seizure Prophylaxis in Glioma (SPRING): A phase III randomised trial comparing prophylactic Levetiracetam versus no prophylactic anti-epileptic drug in newly diagnosed presumed supratentorial glioma.
Session type: Poster / e-Poster / Silent Theatre session
There is no consensus regarding the need for prophylactic anti-epileptic drug (AED) in newly-diagnosed suspected glioma patients who have not experienced seizures. Data regarding prophylactic AED use is scant and inconclusive. Most of the available evidence comes from older, small studies that enrolled patients with brain metastases and benign tumours in addition to gliomas. A definitive randomised clinical trial is needed to determine whether the policy of prophylactic AED therapy reduces the risk of first seizures in this patient population.
SPRING is a two arm, multicentre, phase III RCT of prophylactic AED (Levetiracetam) versus no AED (comparator) in patients with suspected cerebral glioma.
Primary Outcome is one year risk of first seizure. Secondary outcomes include: time to first seizure, time to first tonic-clonic seizure, mood, personality, fatigue and memory and quality of life. Secondary tumour outcomes include: progression free survival and overall survival and incremental cost per QALY.
Patients are randomised 1:1. Levetiracetam will be given at 500mg twice daily for 2 weeks, then increasing to 750mg twice daily thereafter for 1 year. This will not be a blinded study and will not have placebo control. Inclusion criteria includes suspected cerebral glioma on CT/MRI, Capable of giving informed consent, age ≥ 16 years old and Karnofsky performance status of > 60.
Estimate of 1 year seizure rate in patients with suspected glioma after surgery is 20%. Based on a reduction in seizure rate to 10% in the treatment arm, a total of 806 patients will be required.
The trial is in the set up stage and 15 Neuroscience centres will be recruited with planned first enrolment in Jan 2019. The study will recruit for 3 years.
SPRING will be the largest RCT in neuro-oncology, and will include nearly twice as many patients as the previous five RCTs combined.