Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Nanjing Medical University of Collaborative Center
interventional
40
1 country
1
Study Start
January 1, 2021
Actual (reported)Primary Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)August 13, 2024
Actual (reported)August 16, 2024
Actual (reported)January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Intracranial progression-free survival time (iPFS)
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
From enrollment to the end of treatment at 4 weeks
OS (Overall survival)
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
From date of enrollment until the date of progression of existing intracranial metastases, assessed up to 20 months
Cumulative incidence of intracranial failure
From date of enrollment until the date of the progression of existing or new intracerebral metastases assessed up to 20 months
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)
hippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yatian Liu
Nanjing, China
First Submitted
August 13, 2024
First Posted
August 16, 2024
Study Start
January 1, 2021
Actual (reported)Primary Completion
January 1, 2026
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 18, 2025
Record last verified: 2025-03
The results of the study have not been published
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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