Melanoma Cancer Melanoma
Conditions
Interventions
1. Patients will be randomised 1:1 using an Interactive Voice Randomisation System (IVRS)
2. Randomisation will be stratified by centre, gender, number of CNS metastases, extracranial
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/04/2014: 1. One to three intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. It will be assumed that the metastases are melanoma if the patient has documented histological or radiological concurrent extracranial disease that has already made the patient stage IV. If the cerebral lesion(s) is/are the first presentation of stage IV disease, then one metastasis must be histologically proven to be melanoma for the patient to be included in the study 2. Life expectancy of at least 6 months 3. Aged 18 years or older 4. WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation 5. Able to have an MRI brain scan with contrast. Estimated Glomerular Filtration Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI (as per practice guidelines). 6. Localised treatment of all these metastases no more than 6 weeks prior to randomisation 7. An ECOG performance status between 0 and 2 at randomisation 8. CT or PET scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation 9. Serum Lactate Dehydrogenase (LDH) must be = 2 x upper limit of normal 10. Able to provide written informed consent 11. Male or female participants Previous inclusion criteria: 1. One to three intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. It will be assumed that the metastases are melanoma if the patient has documented histological or radiological concurrent extracranial disease that has already made the patient stage IV. If the cerebral lesion(s) is/are the first presentation of stage IV disease, then one metastasis must be histologically proven to be melanoma for the patient to be included in the study 2. Life expectancy of at least 6 months 3. Aged 18 years or older 4. WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation 5. Able to have an MRI brain scan with contrast. Estimated Glomerular Filtration Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI (as per practice guidelines). 6. Localised treatment of all these metastases no more than 6 weeks prior to randomisation 7. An ECOG performance status between 0 and 2 at randomisation 8. CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation 9. Serum Lactate Dehydrogenase (LDH) must be = 2 x upper limit of normal 10. Able to provide written informed consent 11. Male or female participants
Exclusion criteria
Exclusion criteria: 1. Any untreated intracranial disease 2. Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma 3. Evidence of leptomeningeal disease on pre-local treatment MRI scan 4. Patients with prior cancers, except: 4.1. Those diagnosed more than five years ago with no evidence of disease recurrence within this time 4.2. Successfully treated basal cell and squamous cell skin carcinoma 4.3. Carcinoma in-situ of the cervix 5. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol 6. Positive urine pregnancy test for women of childbearing potential (+/-7 days of registration onto the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with distant intracranial failure at 12 months after follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Deterioration in neurocognitive function (NCF) 2. The main neurocognitive function endpoint will be defined as the proportion of patients who have deterioration 3. Overall survival - will be assessed from date of randomisation to date of death from any cause 4. Time to deterioration in health related Quality of Life parameters - the primary QOL endpoint will be time to deterioration in role function from randomisation, with deterioration 5. Time to deterioration in performance status as measured by ECOG - defined as the time that elapses between randomisation and the first recorded worsening (including time to distant intracranial failure) measured by the time difference between the randomisation MRI and Intracranial Failure 6. Time to local intracranial failure measured by the time difference between the pre-randomisation MRI and Intracranial Fail 7. Time to overall (distant + local) intracranial failure, determined through MRI and is defined as the time to the first recurrence of disease anywhere Added 10/04/2014: 8. Incremental cost-effectiveness ratio (ICER). A within-trial economic evaluation of WBRT compared to observation | — |
Countries
England, United Kingdom
Outcome results
None listed