The purpose of this study is to evaluate whether sparing the hippocampi during whole brain radiotherapy following neurosurgery or stereotactic radiosurgery in patients with brain metastases from a systemic tumour helps preserve brain function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
30 Gy in 10 fractions hippocampal sparing whole brain radiotherapy will be administered by Helical Tomotherapy, IMRT, or VMAT
30 Gy in 10 fractions conventional whole brain radiotherapy will be administered
University Hospitals Birmingham NHS Foundation Trust
Birmingham, Greater London, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
Charing Cross Hospital
London, United Kingdom
Total recall assessed using Hopkins Verbal Learning Test-Revised (HVTLR) at 4 months
A decline in total recall will be assessed as being clinically significant if there is at least a 5 point decrease in total recall score at 4 months, compared to baseline \[Jacobson 1991, Brandt 1998\]
Time frame: 4 months after completion of WBRT or HS-WBRT
Neurocognitive function
NCF, using a 30-60 min test battery (Memory - HVLT-R, Wechsler Memory Scale (logical memory subtest), Rey figure test, Wechsler digit span; Attention - Test of Everyday Attention (map search subtest), Trail Making Test (Parts A and B); Language - Graded Naming Test); this may be revised in the light of forthcoming recommendations on NCF assessment in brain metastases trials by the RANO (Revised Assessment in Neuro-oncology) working party
Time frame: 2, 4, 6, 12 and 24 months after completion of WBRT or HS-WBRT
Quality of life
Quality of life will be assessed using EORTC QLQ C30 and BN20 and EuroQol EQ-5D questionnaires
Time frame: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT
Length of time functionally independent
The duration of functional independence will be assessed as the time for which the Karnofsky Performance Status ≥ 70
Time frame: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT
Local control of surgery/SRS treated metastases, local and distant intracranial control (treated and new metastases), and disease control within the hippocampal regions
Incidence of metastases within the perihippocampal region, local control, and intracranial control will be assessed on the basis of MRI imaging
Time frame: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT
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The Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospitals
Nottingham, United Kingdom
Barking, Havering and Redbridge University Hospitals Nhs Trust
Romford, United Kingdom
Overall survival
Date of death will be determined from the medical records, or from the GP
Time frame: followed up until 24 months after completion of WBRT or HS-WBRT
Steroid and antiepileptic medication requirements
Steroid and antiepileptic medication use will be recorded in patient diaries and assessed at clinic visits
Time frame: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT
Acute and late side effects of radiotherapy
Acute and late side effects of radiotherapy will be assessed using NCI CTCAE scale v4.03
Time frame: 2, 4, 6, 9, 12, 18 and 24 months after completion of WBRT or HS-WBRT