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Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

Key facts

Who runs it
Universitaire Ziekenhuizen KU Leuven
Where
Belgium3 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
120 people, planned
Started
8 Feb 2023
Expected to end
1 Feb 2027
Type of study
Interventional
Treatments tested
  • Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test
  • MRI
  • Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI
  • Toxicity scoring
Record updated
8 May 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Adult patients (≥ 18 years at the time of diagnosis) with a primary brain or base of skull tumour, who are amenable for conventionally fractionated radiotherapy (photon or proton irradiation)

Who cannot take part

  • Patients with tumours requiring craniospinal irradiation (CSI)/whole ventricular irradiation (WVI)
  • Hypofractionated/stereotactic radiation (fraction sizes > 2 Gy per fraction)
  • Relapse previously treated by chemo and/or radiation therapy
  • Unable to perform MR imaging (claustrophobia, metallic implants like pacemaker/ICD/neurostimulator)
  • Pre-diagnosis/pre-existing psychiatric diagnosis resulting in cognitive deficits like psychoses, neurodevelopmental disorders (autism/learning disorders)
  • Genetic syndrome (e.g. Down)
  • Patients with tumours with poor prognostic characteristics:; Incompletely resected IDH-wild-type glioma; Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma; grade III meningioma; H3K27M+ midline glioma
  • Inability to perform the cognitive tests or self-report inventories because of motor/sensory deficits or insufficient Dutch language proficiency
  • Mental retardation documented before diagnosis

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The goal of this multicenter prospective longitudinal study is to study the long-term impact of multimodal treatment (chemotherapy, radiotherapy and surgery) in adult brain and base of skull tumors on neurocognitive functioning.

Read full original descriptionShow less

All included patients will complete a self-report inventory (subjective cognitive functioning, QoL, confounders), a cognitive test battery, an advanced MR at multiple timepoints. Moreover, toxicity will be scored according to the CTCAEv5.0 in these patients over time.

The group in the trial

  • Primary brain and skull-base tumorsOther group

    Primary brain and skull-base tumors who are amenable for radiotherapy (photon or proton therapy) will all be examined with neurocognitive tests, questionnaires and advanced MR imaging

    Treatment: Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test, MRI, Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI, and Toxicity scoring

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
Record updated
8 May 2024