Hippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost for BMs of NSCLC
NCT Number: NCT06557187
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Brain Metastases|Non-small Cell Lung Cancer
Interventions: RADIATION: ippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost
Sponsor: Yatian Liu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2023-12-14
Locations: Yatian Liu, Nanjing, China

Summary:
WBRT (whole-brain radiation therapy) exhibits poor tumor control and decreased NCF (neurocognitive function). Herein, we investigated the safety and efficacy of HA-WBRT+SIB (hippocampus-avoidance whole-brain radiation therapy with simultaneous integrated boost) in NSCLC (non-small cell lung cancer) with multiple brain metastases.We conducted a prospective, single-arm phase II trial administering HA-WBRT (30 Gy in 12 fractions, Dmax of the hippocampal volume ≤ 17 Gy, Dmean of the hippocampal volume ≤12 Gy) +SIB (48 Gy in 12 fractions) for multiple brain metastases (≥4) of NSCLC. Intracranial tumor control were compared with patients underwent WBRT by PSM (propensity score matching analysis). Cognitive performance was assessed by the HVLT-R DR (Hopkins Verbal LearningTest-Revised delayed Recall).A-WBRT+SIB emerges as a promising and safe therapeutic, improving intracranial tumor control and protecting cognitive function in NSCLC with multiple brain metastases.

Primary Outcome Measures: Intracranial local progression-free survival time (iLPFS), determined as the time from HA-WBRT+SIB initiation to death, existing intracranial metastases progression, or last follow-up., From date of enrollment until the date of progression of existing intracranial metastases or date of death from any cause, whichever came first, assessed up to 20 months
Secondary Outcome Measures: Intracranial progression-free survival time (iPFS), measured from HA-WBRT+SIB initiation to existing or new metastases intracranial progression, death, or last follow-up., From date of enrollment until the date of progression of existing or new metastases intracranial or date of death from any cause, whichever came first, assessed up to 20 months|Cognitive function, was measured by the relative change in HVLT-R DR score from the start of HA-WBRT+SIB to 4 months after the start of HA-WBRT+SIB., From enrollment to the end of treatment at 4 weeks|OS (Overall survival), described as the time from initiation of radiation to the last follow-up or death, From date of enrollment until the date of death from any cause, whichever came first, assessed up to 20 months|The cumulative incidence of local intracranial failure, measured as the progression of existing intracranial metastases, From date of enrollment until the date of progression of existing intracranial metastases， assessed up to 20 months|Cumulative incidence of intracranial failure, described as the progression of existing or new intracerebral metastases., From date of enrollment until the date of the progression of existing or new intracerebral metastases assessed up to 20 months