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HA-WBRT-SIB for Brain Metastasis of Lung Cancer

Hippocampal Avoidance Whole Brain Irradiation With Simultaneous Integrated Boost for the Treatment of Lung Cancer Brain Metastases:A Prospective Phase II Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06289023
Enrollment
40
Registered
2024-03-01
Start date
2016-01-01
Completion date
2022-12-31
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasm, Brain Metastases, Simultaneous Integrated Boost, Hippocampal Avoidance, Cognitive Function

Keywords

Lung Neoplasm, Brain Metastases, Simultaneous integrated boost, Hippocampal avoidance, Cognitive function

Brief summary

Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, five times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment.

Interventions

RADIATIONHA-WBRT-SIB

A total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV were boosted to 44 Gy-52 Gy in 18-20 fractions, five times a week.

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. pathologically diagnosed primary lung cancer with brain metastasis confirmed via magnetic resonance imaging (MRI); 2. 18-75 years old; 3. BM outside a 10 mm margin around either hippocampus; 4. at least one BM existed if prior resection of BM was done; 5. BM measuring less than 5.0 cm in maximal extent; 6. Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-2

Exclusion criteria

1. previous brain radiotherapy or brain metastasis resection; 2. history of malignancies other than lung cancer; 3. radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases 4. presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months.

Design outcomes

Primary

MeasureTime frameDescription
OS24 monthsthe time from the end of brain radiotherapy to death from any cause

Secondary

MeasureTime frameDescription
PFS24 monthsthe time from the end of brain radiotherapy to tumor progression or death from any cause
iPFS24 monthsthe time from the end of brain radiotherapy to intracranial tumor progression or death from any cause
HVLT-R learning scoreat baseline and 1, 3, and 6 months after radiotherapyThe HVLT scores were calculated as the sum of trials 1, 2, and 3

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026