Clinical trial NCT06618703: Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
Official title: Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 (Direct Cerebral Field or Following Facial, Cervical or High Ear, Nose, and Throat Radiotherapy)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endocrine; Deficiency
Hypothalamo-Pituitary Disorder
Radiotherapy Side Effect
Keywords: Hypothalamic-pituitary axis deficiency
cerebral radiotherapy
brain tumours
endocrine monitoring
follow-up protocol
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-10-01
Enrollment: 230
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention research with minimum risks and constraints
Primary purpose: PREVENTION

Brief summary: 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: Inclusion Criteria:

* 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)
* Signature of informed consent from parents or legal guardian
* Patient affiliated to the social security system or beneficiary of such a system

Exclusion Criteria:

* 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
* Refusal of child or parents

Primary outcomes:
measure: 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)
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Secondary outcomes:
measure: To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: Hormone deficiencies on fatigue in adult patients
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: Hormone deficiencies on cognitive disorders in adult patients
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
measure: Fatigue measurement in patients after the introduction of hormone replacement therapy
timeFrame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Other outcomes:
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