The goal of this clinical trial is to evaluate whether a higher dose of radiotherapy can lead to better outcomes for participants with functioning pituitary tumours. The main question it aims to answer is whether a greater proportion of participants will achieve normal hormone levels with the higher dose of proton beam radiotherapy than with standard radiotherapy treatment doses.
Following randomisation, participants will receive approximately 6 weeks of either standard dose radiotherapy (intensity-modulated radiation therapy or proton beam therapy, depending on age) OR escalated dose proton beam therapy. Following this, participants will be followed up for at least 2 years to monitor their condition. This includes pituitary, hormone level, tumour, neurocognitive, and ophthalmology assessments, as well as patient-reported quality of life outcomes and health economic measures.
Neuropathological confirmation of growth hormone (acromegaly) or ACTH (Cushing's disease) secreting pituitary adenoma after neurosurgical intervention.
Ongoing hormonal hypersecretion as defined by local and age-specific normal range values without hormone supressing medication (may need washout).
Multidisciplinary team meeting recommendation for fractionated radiotherapy.
Karnofsky performance status ≥70.
Women who are pregnant or breast feeding.
Prior cranial or head and neck radiotherapy treatment, including Stereotactic radiosurgery (SRS).
Unsuitability or intolerability of MRI scans.
Severe active comorbidities that limit compliance with trial requirements.
Parallel
Standard dose Intensity-Modulated Radiation Therapy (IMRT)
RadiationStandard dose IMRT (1.8Gy per fraction)
Standard dose Proton Beam Therapy (PBT)
RadiationStandard dose PBT (1.8Gy per fraction)
Escalated dose Proton Beam Therapy (PBT)
RadiationEscalated dose PBT (2Gy per fraction)
Time to normalisation of hormone levels
Time to normalisation of hormone levels (i.e. growth hormone (GH) or insulin growth factor 1 (IGF-1)) following randomised treatment
Radiological treatment response
Data from MRI scans assessed for rates of stability, regression, and. progression. Overall response rate will be presented.
Radiological progression-free survival (PFS)
Progression-free survival (progression determined from an MRI scan).
Medical therapies for hormone excess
The number and proportion of participants requiring new/changes to medical therapy for hormone excess at each visit.
Changes to hormone levels
Hormone levels relevant to the participant's disease (e.g. growth hormone \[GH\]) will be measured at each trial visit, summarised, and compared over time between treatment arms.
Health Economic Evaluation
The health economic analysis will calculate the mean incremental cost per quality-adjusted life-years (QALYs) gained on using dose-escalated proton beam therapy compared to standard dose radiotherapy.
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University College, London
Lead sponsor
National Institute for Health and Care Research
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
