Precision Radiation Treatment for Epilepsy (PRECISION)

Last updated: May 16, 2024
Sponsor: Maastricht Radiation Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

LINAC-based Stereotactic Radiotherapy

Clinical Study ID

NCT05182437
80-86200-98- 25008
  • Ages > 18
  • All Genders

Study Summary

The PRECISION-study offers a non-invasive, curative intervention for drug-resistant localised epilepsy patients who are not eligible for surgery. The intervention will consist of a single LINAC based SRT treatment and is given by the radiation-oncologist after detailed localisation of the epileptogenic zone with the neurologist, radiologist and neurosurgeon.

This intervention will make curative-intent treatment possible where this could otherwise not be given and is a non-invasive and non-competitive alternative to epilepsy surgery. It is expected that the health costs for this curative treatment will not exceed standard treatment, such as lifelong medication and neuromodulation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Before patient registration/randomization, written informed consent must be givenaccording to ICH/GCP, and national/local regulations

  3. Willingness to use contraception by a method that is deemed effective by theInvestigator during the SRT treatment and for at least 30 days following the SRTtherapy

  4. The patient or caretaker is able to keep an epilepsy diary

  5. The patient has a diagnosis of epilepsy established by a dedicated neurologist

  6. The patient had at least 3 focal-onset seizures over a 3-month period despite two ormore antiepileptic medication trials (according ILAE Task Force on therapeuticstrategies)

  7. Video electroencephalography and work-up in the epilepsy surgery working group todetermine a well-circumscribed seizure focus is available

  8. Evidence (e.g. 3T-MRI or a clear SEEG delineation) of the anatomic region to betargeted with SRT, correlating with the EZ hypothesis;

  9. A functional MRI to lateralize language or localize visual, motor and/or sensoryeloquent cortex has been performed in selected patients (if the lesion is expectedto be located, based on anatomy, in the language areas).

  10. The patient has completed a standard battery of neuropsychological testing

  11. The patient been deemed an appropriate candidate for stereotactic radiosurgery by adedicated Radiation Oncologist and Neurosurgeon/Epileptologist and referred for thestudy by one of the Dutch regional multidisciplinary epilepsy surgery working groups

  12. Patients that were rejected for surgery in an earlier stage can participate in thetrial if the last change of the NVS/DBS settings were more than 1 year ago orNVS/DBS was not (yet) tried.

Exclusion

Exclusion Criteria:

  1. Pregnancy

  2. If a radiation treatment plan without exceeding the constraints for the organs atrisk is not feasible.

  3. Prior cranial radiotherapy

  4. If radiotherapy treatment is not possible for diverse reasons.

  5. If the subject has clinically significant and uncontrolled major other medicalcondition(s) including but not limited to:

ii. psychiatric illness/social situation that would limit compliance with study requirements iii. any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities iv. Progressive co-morbidity which limits overall survival.

Study Design

Total Participants: 94
Treatment Group(s): 1
Primary Treatment: LINAC-based Stereotactic Radiotherapy
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
January 01, 2028

Study Description

In this PRECISION-study including adult patients with drug-resistant, localised epilepsy, not eligible for surgery, we offer non-invasive linear accelerator (LINAC) based Stereotactic Radiotherapy (SRT) with curative intent.

SRT and stereotactic radio-surgery (SRS) have been used to treat several types of neoplasms in the brain for several decades. Several publications (level 2 evidence) have shown the potential value of SRT in patients with drug-resistant epilepsy, however no level-1 evidence was given enabling guideline development. A recent systematic review from our institution has shown that SRT resulted in a significant seizure cure or reduction in 58% of the 170 included patients, within 2 years after treatment. Interestingly, the ROSE trial, randomising between open surgery and SRT, has demonstrated a seizure remission of 52% in the radiotherapy group after 2 years with the proportion of seizure-free patients still increasing with a longer follow-up up to 74% after 3 years. Therefore, SRT may be considered a curative treatment for drug resistant localised epilepsy. Currently, randomized controlled SRT epilepsy trials are lacking and there is a need for high quality evidence, so SRT can be clinically implemented for localised drug-resistant epilepsy patients in the Netherlands as well.

The PRECISION-study is a randomised waitlist-controlled trial in which SRT is the intervention and AED continuation and neuromodulation are the standard treatment with a 1:1 randomization. After 2-year follow up the waitlist-control group, patients are offered the intervention (optional).

We hypothesize that SRT alters the epileptogenic cerebral tissue to yield a reduction in seizures and possibly cure after 2 years, with a significant increase in the patients' quality of life.

Connect with a study center

  • Maastricht Radiation Oncology

    Maastricht, Limburg 6202 AZ
    Netherlands

    Active - Recruiting

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UVA)

    Amsterdam, Noord-Holland 1007 MB
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht,
    Netherlands

    Site Not Available

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