2-15 brain metastases treat with stereotactic radiosurgery or hippocampal avoidance whole brain radiation with simultaneous integrated boost Brain metastasis Brain metastases Stereotactic radiosurgery SRS Stereotactic radiotherapy SRT Radiosurgery Whole brain radiation Hippocampus Hippocampi Hippocampal avoidance Hippocampal sparing Simultaneous integrated boost SIB Cognitive function Cognition Quality of life Cost effectiveness Cost utility
Conditions
Interventions
SRS 15-24 Gy/1 Fraction
SRT 21-30 Gy/3 Fraction
SRT 25-35 Gy/5 Fraction,HA-WBRT 30 Gy/10 Fraction
SIB 35-45 Gy/10 Fraction
Stereotactic radiosurgery,Hippocampal avoidance whole brain radiation with simultaneous integrated boost
Sponsors
Routine to Research Unit, Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Pre-registration inclusion criteria 1. Age 18 years or more 2. KPS 70 or more, or ECOG 0-2 3. Histologically proven malignancy 4. CT and/or MRI performed within 1 month prior registration confirmed brain metastases 2-15 lesions 5. All brain metastases 3 cm. or smaller 6. Life expectancy 6 months or more according to brainmet.gpa (for primary lung cancer, breast cancer, melanoma, renal cell carcinoma and GI malignancy), otherwise evaluated by treating physician 7. Progressive brain metastasis following systemic treatment with effective intracranial activity is eligible 8. Resection of brain metastasis with planned postoperative radiation is eligible Additional inclusion criteria at time of MRI simulation 1. Eligible for HA-WBRT+SIB and/or SRS/SRT - No lesion within 5 mm. around hippocampi, otherwise ineligible for HA-WBRT+SIB - No lesion closed or adjacent to critical structures (e.g. optic pathways, cranial nerve, brainstem) that may preclude safe radiation, otherwise ineligible for SRS/SRT and/or HA-WBRT+SIB 2. Number of brain metastases 25 lesions or less 3. Total brain metastatic volume 30 cc or less
Exclusion criteria
Exclusion criteria: Pre-registration exclusion criteria 1. Pregnant or nursing women 2. Inability to complete an MRI scan with contrast 3. Planned chemotherapy during RT (targeted therapy or immunotherapy was allowed) 4. Previous cranial RT 5. Diffuse leptomeningeal metastases 6. Massive perilesional edema 7. Primary germ-cell tumor, small-cell carcinoma, or lymphoma 8. Known case of psychiatric disorders or neurodegenerative diseases Additional exclusion criteria after radiotherapy treatment planning - Unable to achieve safe radiotherapy treatment plans (e.g. major deviation from treatment protocol, unacceptable dose constraint to critical structure) for both SRS/SRT and HA-WBRT after switching from SRS/SRT to HA-WBRT+SIB or vice versa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life 6 and 12 months Questionnaire Functional Assessment of Cancer Therapy Brain (FACT-Br) and EuroQol EQ-5D-5L | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional independence 6 and 12 months Barthel Index for Activities of Daily Living (ADL) ,Neurocognitive function 6 and 12 months Montreal Cognitive Assessment (MoCA) Test,local failure, distance brain failure, intracranial progression, radiographic response 6 and 12 months Magnetic resonance imaging (MRI) brain,Overall survival 6 and 12 months Clinical follow-up and Civil registration database,Salvage brain treatment 6 and 12 months Clinical follow-up,Toxicity 6 and 12 months Common Terminology Criteria for Adverse Events (CTCAE),Cost utility 6 and 12 months Quality-adjusted life year (QALY) | — |
Countries
Thailand
Contacts
Public ContactAchiraya Teyateeti
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed