Hippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost for BMs of NSCLC

NCT06557187 | Active Not Recruiting

• 2 other identifiers: JZ233490202001088100000RMB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Metastases; Non-small Cell Lung Cancer

Keywords

brain metastases; hippocampus-avoidance; whole-brain radiation therapy; simultaneous integrated boost

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Hippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost

EXPERIMENTAL

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)

Radiation: ippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost

Interventions

ippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost RADIATION

hippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost

Hippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (aged 18-75 years) diagnosed with NSCLC, with a KPS (Karnofsky performance status) ≥70, at least four brain metastases visible on MRI (magnetic resonance imaging) outside a 5-mm margin around the bilateral hippocampi, not suitable for targeted therapy or progressing intracranial post targeted therapy.

You may not qualify if:

• Ineligible participants had a history of conditions affecting cognitive function (including mental illness, brain trauma, and Alzheimer\'s disease), other primary malignant tumors, uncontrolled systemic disease, uncontrolled extracranial sites of gross disease, and suitable for targeted therapy.

Sponsors & Collaborators

• Yatian Liu: lead

Study Sites (1)

Yatian Liu

Nanjing, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Nanjing Medical University and Deputy chief physician in Jiangsu Cancer Hospital

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)