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NCT Number: NCT06618703

Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years

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.

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Key information

Conditions

Endocrine; Deficiency Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Hypothalamo-Pituitary Disorder Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample, urine sample, osteodensitometry

Radiation

Blood sample, urine sample, osteodensitometry

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)

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Measurement of hormon level for :

    • growth hormone deficiency
    • gonadal insufficiency
    • hypothyroidism
    • adrenal insufficiency

Secondary outcomes

  1. To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    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).

  2. To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Maximum dose (Dmax): The maximum dose received by a small portion of tissue in these critical organs.

  3. To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Volume irradiated (%): This parameter measures the proportion of the organ exposed to radiotherapy.

  4. To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Average dose (Dmean) and D50%: The average and median dose received by the whole organ.

  5. To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Minimum dose (Dmin): minimum dose received by the organ.

  6. To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Dose-volume histogram (DVH): The DVH analysis enables you to visualize the dose distribution over the entire organ, and to identify any thresholds other than those listed above.

  7. Hormone deficiencies on fatigue in adult patients

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions.

    5-point Likert scale from: 0 (Never) to 4 (Almost always) 3-point Likert scale from: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Child Report for Young Children (ages 5-7) then Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0

  8. Hormone deficiencies on cognitive disorders in adult patients

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions.

    5-point Likert scale from: 0 (Never) to 4 (Almost always) 3-point Likert scale from: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Child Report for Young Children (ages 5-7) then Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0

  9. Fatigue measurement in patients after the introduction of hormone replacement therapy

    Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

    Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions.

    5-point Likert scale from: 0 (Never) to 4 (Almost always) 3-point Likert scale from: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Child Report for Young Children (ages 5-7) then Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Demoor-Goldschmidt, Dr

CONTACT

[email protected]

0241353565 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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)

Acronym: BIChE-1

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Oct 1, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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