Precision Radiation Treatment for Epilepsy (PRECISION)

NCT05182437 | Active Not Recruiting

• 1 other identifier: 80-86200-98- 25008
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Radiotherapy adapted Engel classification (RAEC) is I, II or III

  Radiotherapy adapted Engel classification (RAEC). For analysis of outcomes in the incidence of seizures, we use in this study the Engel classification, adapted for radiotherapy. This includes four classes: class I - seizure free, class II - rarely seizures, class III improved, more than 75% IV- no significant improvement.

  Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

Secondary Outcomes (10)

• Seizure frequency

  Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

• Seizure-free days

  Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

• Type of epilepsy

  Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

• EQ-5D 5 Level (EQ-5D-5L)

  Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

• The Assessment of Quality of Life-8 Dimensions Score (AQoL-8D Score)

  Baseline (before treatment), 1 year, 2 year, 3 year, 4 year and 5 year after treatment

Study Arms (2)

LINAC-based Stereotactic Radiotherapy

EXPERIMENTAL

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 (EZ) with the neurologist, radiologist and neurosurgeon.

Radiation: LINAC-based Stereotactic Radiotherapy

Randomised waitlist-controlled trial

OTHER

The first 2 years after randomization stardard treatment (AED continuation and neuromodulation). After 2-year follow up the waitlist-control group, patients are offered the intervention (LINAC-based Stereotactic Radiotherapy). This intervention is optional

Radiation: LINAC-based Stereotactic Radiotherapy

Interventions

LINAC-based Stereotactic Radiotherapy RADIATION

Target definition: the target volume is defined as the epileptogenic zone (EZ) on all (non) invasive examinations (e.g. 3, 7 Tesla MRI or Stereo-EEG) of the presurgical path. Planning target volume (PTV) = GTV. A single fraction SRT with a prescribed isotoxic dose of 24 Gy to the 100% surrounding isodose. Dose is depending on the proximity and maximum tolerable dose to the radiosensitive organs at risk and EZ volume resulting in a V12\<= 10 cc reducing the risk on radionecrosis.

LINAC-based Stereotactic Radiotherapy; Randomised waitlist-controlled trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
• Willingness to use contraception by a method that is deemed effective by the Investigator during the SRT treatment and for at least 30 days following the SRT therapy
• The patient or caretaker is able to keep an epilepsy diary
• The patient has a diagnosis of epilepsy established by a dedicated neurologist
• The patient had at least 3 focal-onset seizures over a 3-month period despite two or more antiepileptic medication trials (according ILAE Task Force on therapeutic strategies)
• Video electroencephalography and work-up in the epilepsy surgery working group to determine a well-circumscribed seizure focus is available
• Evidence (e.g. 3T-MRI or a clear SEEG delineation) of the anatomic region to be targeted with SRT, correlating with the EZ hypothesis;
• A functional MRI to lateralize language or localize visual, motor and/or sensory eloquent cortex has been performed in selected patients (if the lesion is expected to be located, based on anatomy, in the language areas).
• The patient has completed a standard battery of neuropsychological testing
• The patient been deemed an appropriate candidate for stereotactic radiosurgery by a dedicated Radiation Oncologist and Neurosurgeon/Epileptologist and referred for the study by one of the Dutch regional multidisciplinary epilepsy surgery working groups
• Patients that were rejected for surgery in an earlier stage can participate in the trial if the last change of the NVS/DBS settings were more than 1 year ago or NVS/DBS was not (yet) tried.

You may not qualify if:

• Pregnancy
• If a radiation treatment plan without exceeding the constraints for the organs at risk is not feasible.
• Prior cranial radiotherapy
• If radiotherapy treatment is not possible for diverse reasons.
• If the subject has clinically significant and uncontrolled major other medical condition(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.

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator
• UMC Utrecht: collaborator
• Amsterdam University Medical Center: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (2)

• Eekers DBP, Pijnappel EN, Schijns OEMG, Colon A, Hoeben A, Zindler JD, Postma AA, Hoffmann AL, Lambin P, Troost EGC. Evidence on the efficacy of primary radiosurgery or stereotactic radiotherapy for drug-resistant non-neoplastic focal epilepsy in adults: A systematic review. Seizure. 2018 Feb;55:83-92. doi: 10.1016/j.seizure.2018.01.009. Epub 2018 Jan 31.

  PMID: 29414140 BACKGROUND

• Zegers CML, Swinnen A, Roumen C, Hoffmann AL, Troost EGC, van Asch CJJ, Brandts L, Compter I, Dieleman EMT, Dijkstra JB, Granzier M, Hendriks M, Hofman P, Houben RMA, Ramaekers B, Ronner HE, Rouhl RPW, van der Salm S, Santegoeds RGC, Verhoeff JJ, Wagner GL, Zwemmer J, Schijns O, Colon AJ, Eekers DBP. High-precision stereotactic irradiation for focal drug-resistant epilepsy versus standard treatment: a randomized waitlist-controlled trial (the PRECISION trial). Trials. 2024 May 21;25(1):334. doi: 10.1186/s13063-024-08168-9.

  PMID: 38773643 DERIVED

Related Links

• Publication Pubmed

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daniëlle Eekers, Dr.

  Radiation Oncologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial Observational Model : Experimental Time Perspective : Prospective

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: January 10, 2022
• Study Start: December 1, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)