Hippocampal radiation dose and memory in children treated for brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, multicenter study enrolling children who received localized or craniospinal radiotherapy for selected brain tumors between ages 4 and 12. Neuropsychological testing, parental questionnaires, and neuroimaging will measure declarative memory, attention, and brain changes at about 2 years and 4 years after radiotherapy, with a retrospective parental report of baseline function one year before diagnosis. Radiation dose to the hippocampus will be reconstructed from photon or proton treatment plans and correlated with memory outcomes to define dose–response relationships. The study is carried out at several French oncology centers and requires French language proficiency and social security coverage.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient who has received localised brain irradiation or craniospinal irradiation for a brain tumour whose treatment includes first-line radiotherapy.
2. Patient with one of the following tumour types: ependymomas, medulloblastomas, malignant germ cell tumours, craniopharyngioma, pinealoblastoma.
3. Patient aged between 4 and 12 years at the time of radiotherapy treatment.
4. End of irradiation within 2 years (+/-3 months) prior to inclusion.
5. Patient having been treated by photontherapy or proton therapy.
6. Sufficient visual, auditory (with authorised hearing aid) and oral or written expression capacity to carry out the neuropsychological tests properly.
7. Proficiency in the French language by the patient and parent(s).
8. Patient affiliated to a Social Security scheme in France.
9. Informed consent signed by the patient/legal parent(s)/guardian(s) in accordance with French law and Good Clinical Practice.

Exclusion Criteria:

1. Patient presenting with severe ataxia.
2. Patient with a recurrence of the disease.
3. Not applicable since protocol version 2. Metastatic patient.
4. Any contraindication to MRI for patients included in Toulouse (i.e. in particular patients with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patients with haemostatic clips on intracerebral aneurysms, patients with orthopaedic implants, claustrophobic patients).
5. Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants).
6. Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and/or the procedures set out in the study protocol.
7. Patients deprived of their liberty or under legal protection.
8. Severe posterior fossa syndrome with akinetic mutism.

Where it's running

• CHU Angers
  Angers, France Recruiting
• CHU de Bordeaux
  Bordeaux, France Recruiting
• Centre François Baclesse
  Caen, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting
• APHM - Hôpital la Timone
  Marseille, France Recruiting
• Centre Eugène Marquis
  Rennes, France Recruiting

Study contacts

• Study coordinator: Anne LAPRIE
• Email: laprie.anne@iuct-oncopole.fr
• Phone: 05 31 15 54 43

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.