Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years (BIChE-1)

University Hospital, Angers

Status: Not yet enrolling

Conditions: Radiotherapy Side Effect; Endocrine; Deficiency; Hypothalamo-Pituitary Disorder

Treatments: Radiation: Blood sample, urine sample, osteodensitometry

Study type: Interventional

Funder types: Other

Identifiers

NCT06618703

49RC24_0193

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Study Arm

Experimental group

Description:

Specific interventions: For all patients, an insulin level is added every 2 years. For patients under 8 years of age, additional elements such as testosterone (in male patients), Luteinizing hormone , Follicle-stimulating hormone, estradiol (in female patients), inhibin B +/- Anti-Müllerian hormone are measured during the usual blood test. A urinary check-up is systematically added for all patients, whereas it is usually only prescribed after certain chemotherapies (platinum salts, ifosfamide), nephrectomy, radiotherapy to the flanks as part of routine care. This check-up will be carried out at 2 and 4 years post-radiotherapy. For patients aged 12 and over, a second bone densitometry is performed at the end of follow-up, even if the first is normal. In routine care, international guidelines recommend this first bone densitometry, and the second is usually performed only if the first was abnormal.

Treatment:

Radiation: Blood sample, urine sample, osteodensitometry