Background: Whole brain radiation therapy (WBRT) is the standard therapy for multiple brain metastases. However, WBRT has a poor local tumor control and is associated with a decline in neurocognitive function (NCF). Aim of this trial is to assess the efficacy and safety of a new treatment method, the WBRT with hippocampus avoidance (HA) combined with the simultaneous integrated boost (SIB) on metastases/resection cavities (HA-WBRT+SIB). Methods: This is a prospective, randomized, two-arm phase II multicenter trial comparing the impact of HA on NCF after HA-WBRT+SIB versus WBRT+SIB in patients with multiple brain metastases. The study design is double-blinded. One hundred thirty two patients are to be randomized with a 1:1 allocation ratio. Patients between 18 and 80 years old are recruited, with at least 4 brain metastases of solid tumors and at least one, but not exceeding 10 metastases ≥5 mm. Patients must be in good physical condition and have no metastases/resection cavities in or within 7 mm of the hippocampus. Patients with dementia, meningeal disease, cerebral lymphomas, germ cell tumors, or small cell carcinomas are excluded. Previous irradiation and resection of metastases, as well as the number and size of metastases to be boosted have to comply with certain restrictions. Patients are randomized between the two treatment arms: HA-WBRT+SIB and WBRT+SIB. WBRT is to be performed with 30 Gy in 12 daily fractions and the SIB with 51 Gy/42 Gy in 12 daily fractions on 95% of volume for metastases/resection cavities. In the experimental arm, the dose to the hippocampi is restricted to 9 Gy in 98% of the volume and 17Gy in 2% of the volume. NCF testing is scheduled before WBRT, after 3 (primary endpoint), 9, 18 months and yearly thereafter. Clinical and imaging
Following completion of a 1-day P-FAST course, participants were able to perform ultrasound procedures at the scene of an accident with a high level of accuracy.
Background
The focused assessment with sonography in trauma (FAST) exam is an established trauma care diagnostic procedure. Ultrasound performed during prehospital care can improve early treatment and management of the patients. In this prospective randomized clinical trial, we wanted to assess whether a pre-hospital FAST (p-FAST) influences pre-hospital strategy and the time to operative treatment.
Methods
We studied 296 trauma victims in a prehospital setting. Inclusion criteria were potential abdominal injuries identified either by clinical examination or suggested by the mechanism of injury. Physician-staffed helicopters and emergency ambulances were equipped with portable ultrasound devices. According to a scheme related to calendar weeks, a clinical exam only (CEX) or a clinical exam together with a p-FAST (CEX-p-FAST) was conducted. Outcome variables were prehospital diagnosis and strategy, the time to admission to the trauma room and to operation theater. The study was approved by the university ethical committee (REB#: 46/06).
Results
CEX-p-FAST showed a high sensitivity (94.7%) and specificity (97.6%) in detection of free fluid compared to CEX-only (80.0%, 84.4%). The median time to admission was reduced significantly by 13 min and to operative treatment by 15 min after CEX-p-FAST. We observed a cross-over rate of 30.8% of p-FAST (n = 36) to CEX-p-FAST during the CEX-only weeks.
Conclusion
According to the experience of the principal investigators, CEX-p-FAST was superior to CEX-only. Despite the time needed for p-FAST, the relevant admission time was significantly shorter. Thus, p-FAST is recommended in addition to CEX if possible for decision-making in prehospital trauma care.
Trial registration
German Clinical Trials Register #DRKS00022117—Registered 10 July 2020—Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022117.
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