A study to see if earlier and more hormonal testing can detect problems sooner in patients who have had radiotherapy treatment for brain tumours
| ISRCTN | ISRCTN71114440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71114440 |
| IRAS number | 358898 |
| Secondary identifying numbers | RG_24-069 |
- Submission date
- 18/06/2025
- Registration date
- 02/07/2025
- Last edited
- 19/06/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
After radiotherapy for brain tumours, some patients can develop hormone problems because of the effects on the brain’s hormone control centre. Right now, hormone levels are usually only checked once, a year after treatment ends. The ENDORADS study wants to find out if checking hormone levels more often—every four months for two years—can help spot problems earlier. This could mean patients get treatment sooner, which might reduce long-term side effects. The study will also look at whether this more frequent testing works well for both patients and hospitals.
Who can participate?
The study is for people who have had radiotherapy to the brain for a primary brain tumour and meet certain medical criteria. A doctor will check if someone is eligible to take part.
What does the study involve?
If you join the study, your hormone levels will be tested every four months for two years after your radiotherapy ends. These tests are usually done through blood samples. The study team will monitor your results and share them with your medical team, who will decide if any treatment is needed.
What are the possible benefits and risks of participating?
The main benefit is that hormone problems might be found and treated earlier, which could help reduce long-term health issues. The risks are small and mainly related to the inconvenience of more frequent blood tests, which some people may find uncomfortable or time-consuming.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
October 2024 to September 2028.
Who is funding the study?
Stand Up To Cancer and Cancer Research UK.
Who is the main contact?
endorads@trials.bham.ac.uk
Contact information
Scientific, Principal Investigator
The Christie NHS Foundation Trust, Wilmslow Road, Withington
Manchester
M20 4BX
United Kingdom
 ORCID ID |
0000-0002-5138-0707 |
|---|---|
| Phone | +44 1614463000 |
| martin.mccabe@nhs.net |
Public
CRCTU, University of Birmingham, Vincent Drive, Edgbaston
Birmingham
B15 2TT
United Kingdom
| ORCID ID |
0000-0001-9886-0161 |
|---|---|
| Phone | +44 121 414 8040 |
| endorads@trials.bham.ac.uk |
Study information
| Study design | Multicenter interventional feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Early eNDOcrine intervention after brain RADiotherapy feasibility Study |
| Study acronym | ENDORADS |
| Study objectives | Earlier and more frequent hormonal and metabolic testing will detect hormonal and metabolic deficiencies sooner after radiotherapy treatment |
| Ethics approval(s) |
Not yet submitted, unknown (unknown, Unknown, unknown, United Kingdom; unknown; Email not provided), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Tumour of the central nervous system where 10Gy or more radiotherapy has been received to the hypothalamus or pituitary gland |
| Intervention | Patients who have had radiotherapy for a brain tumour will be approached to take part in the study. When they have consented, they will undergo hormonal and metabolic testing every 4 months from the end of their radiotherapy treatment until 2 years after the end of radiotherapy. They will have 6 testing timepoints in this period. There is no follow-up period, therefore participants will be on study for 2 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to develop biochemical Growth Hormone deficiency Time from end of radiotherapy treatment to develop biochemical Growth Hormone deficiency is defined as the difference between date of end of radiotherapy treatment and date of the first abnormal Growth Hormone test, as defined by each site’s local range. Biochemical Growth Hormone deficiency will be defined if the test results of the dynamic testing for Growth Hormone are abnormal. |
| Secondary outcome measures | 1. Time to develop Growth Hormone deficiency is measured using local diagnosis based on dynamic testing for Growth Hormone, IGF-1, IGFBP3, height velocity, and weight velocity at baseline and follow-up timepoints 2. Time to develop Growth Hormone deficiency is measured using central diagnosis based on central review of dynamic testing for Growth Hormone, IGF-1, IGFBP3, height velocity, and weight velocity at baseline and follow-up timepoints 3. Proportion of patients with completed testing is measured using test completion records at each timepoint 4. Number of hypothalamic-pituitary axes with documented deficiency is measured using local reference ranges for ACTH/Cortisol, thyroid, gonadotropin, prolactin, and arginine vasopressin axes at each timepoint 5. Time to develop measurable hypothalamic-pituitary deficiency is measured using local reference ranges for each axis based on the date of first abnormal test result at baseline and follow-up timepoints 6. Number of hypothalamic-pituitary axes with documented deficiency is measured using local diagnosis based on site review of hypothalamic-pituitary tests at each timepoint 7. Time to develop measurable hypothalamic-pituitary deficiency is measured using local diagnosis based on site review of hypothalamic-pituitary tests at baseline and follow-up timepoints 8. Number of hypothalamic-pituitary axes with documented deficiency is measured using central diagnosis based on central review of hypothalamic-pituitary tests at each timepoint 9. Time to develop measurable hypothalamic-pituitary deficiency is measured using central diagnosis based on central review of hypothalamic-pituitary tests at baseline and follow-up timepoints 10. Number of metabolic tests with documented dysfunction is measured using local reference ranges for glucose, insulin, HbA1c, lipids, liver function, blood pressure, and BMI at each timepoint 11. Time to develop metabolic dysfunction is measured using local reference ranges for each metabolic test and overall dysfunction based on the date of first abnormal test result at baseline and follow-up timepoints 12. Number of metabolic tests with documented dysfunction is measured using local diagnosis based on site review of metabolic tests at each timepoint 13. Time to develop metabolic dysfunction is measured using local diagnosis based on site review of metabolic tests at baseline and follow-up timepoints 14. Number of metabolic tests with documented dysfunction is measured using central diagnosis based on central review of metabolic tests at each timepoint 15. Time to develop metabolic dysfunction is measured using central diagnosis based on central review of metabolic tests at baseline and follow-up timepoints 16. Proportion of patients who receive treatment is measured using treatment records for each axis within one and two years of end of radiotherapy 17. Time to treatment is measured using treatment records for each axis based on the date of treatment initiation within one and two years of end of radiotherapy 18. Reasons for non-treatment where deficiencies are identified are measured using clinical documentation for each test |
| Overall study start date | 01/10/2024 |
| Completion date | 28/09/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 0 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Aged 25 years or under at the end of cranial radiotherapy 2. Cranial irradiation for a primary central nervous system tumour 3. Trial recruitment within 8 months of the completion of cranial irradiation. If craniospinal radiotherapy is given, the cranial component must have completed within the previous 8 months 4. Hypothalamic or pituitary dose of ≥ 10 Gy 5. Written informed consent from the patient and/or parent/legal guardian |
| Key exclusion criteria | 1. Serial dynamic hypothalamic assessments not possible due to social, geographic or psychological reasons 2. Patients with a hypothalamic-pituitary (HP) axis tumour having hypopituitarism including Growth Hormone deficiency at tumour diagnosis or after surgery 3. Patients with evidence of Growth Hormone deficiency 4. Females who are pregnant or breastfeeding |
| Date of first enrolment | 29/09/2025 |
| Date of final enrolment | 28/09/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Birmingham
B4 6NH
United Kingdom
London
WC1N 3JH
United Kingdom
West Derby
Liverpool
L12 2AP
United Kingdom
Sheffield
S10 2TH
United Kingdom
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Sponsor information
University/education
Vincent Drive
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 7814650003 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Unidos Contra El Cáncer, SU2C
- Location
- United States of America
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/09/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
18/06/2025: Trial's existence confirmed by Stand up to cancer.
