Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorUniversity Hospital, Angers
About this trial
BICHE- 1: Brain Irradiation for Childhood cancer - Endocrine monitoring during the first five years is a study of endocrine monitoring after cerebral radiotherapy.
The study concerns patients in remission at the end of oncological treatment aged between 4 and 18 years at the time of inclusion and who have had radiotherapy before the age of 16, irradiating all or part of the brain, with a delay between the end of radiotherapy and inclusion of less than 5 years. Patients will be included during a routine visit to the paediatric endocrinologist.
The protocol for the Biche 1 study has been designed and discussed in a multidisciplinary and multicentre manner, based on data from the literature and the French reference document (September 2021) "National protocol for diagnosis and care - congenital pituitary deficiency".
In this population, the investigators will conduct a descriptive and exploratory study to establish recommendations for medium-term follow-up; to improve screening for endocrine deficiencies affecting the hypothalamic-pituitary axis in order to improve patients' quality of life and state of health; and to better define dose-volume constraints on the axis.
The study will also focus on better detection and characterisation of chronic fatigue as a potential sequela of pituitary deficiencies, in particular by means of a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) which will also be systematically administered and completed annually.The expected sample size is 100-150 patients treated for a brain tumour and 60-80 patients treated for another tumour but with an irradiation field covering all or part of the brain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 4 years or more (≥4) and less than 18 years (<18) at inclusion
Treated with radiotherapy to part or all of the brain for cancer or hematological malignancy before age 16 (≤15)
Post-radiotherapy time less than or equal to 5 years (≤5)
In remission of this pathology at the end of oncological treatments, or, with stable residual disease without treatment for 2 years or more (≥2)
Disqualifiers
Patients who have relapsed or developed a second cancer with a post-treatment delay of < 1 year
Patient in palliative situation
Brain irradiation with dosimetric data showing sparing of the hypothalamic-pituitary axis (Dmax hypothalamic-pituitary axis < 15 Gy)
Patient with a known hypothalamic-pituitary axis endocrine deficit prior to radiotherapy
Trial design
Design model
Single group
Treatments tested in this trial
Blood sample, urine sample, osteodensitometry
RadiationBlood sample, urine sample, osteodensitometry
Treatment groups
230 Participants
are divided into 1 treatment groupGroup A: Study ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Endocrine toxicities assessment after radiotherapy involving all or part of the brain in children, adolescents and young adults treated for cancer before the age of 16 (≤15 years)
Measurement of hormon level for : * growth hormone deficiency * gonadal insufficiency * hypothyroidism * adrenal insufficiency
Time frame
Follow-up of 4 years, within a maximum of 5 years post-radiotherapySecondary outcomes
1
To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
Dose absorbed (Gy) by sensitive organs: This parameter corresponds to the total amount of radiation absorbed by the hypothalamus and pituitary gland, two key structures of the endocrine axis. A cumulative dose above certain thresholds is associated with a higher risk of long-term endocrine dysfunction - possibly after adjustment for the biological equivalent dose (which also takes fractionation into account).
Time frame
Follow-up of 4 years, within a maximum of 5 years post-radiotherapy2
To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
Maximum dose (Dmax): The maximum dose received by a small portion of tissue in these critical organs.
Time frame
Follow-up of 4 years, within a maximum of 5 years post-radiotherapy3
To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
Volume irradiated (%): This parameter measures the proportion of the organ exposed to radiotherapy.
Time frame
Follow-up of 4 years, within a maximum of 5 years post-radiotherapy4
To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
Average dose (Dmean) and D50%: The average and median dose received by the whole organ.
Time frame
Follow-up of 4 years, within a maximum of 5 years post-radiotherapySponsors and contacts
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Source ClinicalTrials.gov