Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC

Study Overview
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Brief Summary
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This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.

Official Title
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A Phase II Multi-institutional Study of Hippocampus-sparing Whole Brain Radiotherapy and Simultaneous Integrated Boost for Multiple Brain Metastases From Non-small Cell Lung Cancer

Conditions
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Brain Metastases

Intervention / Treatment
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* Radiation: WBRT with hippocampus-sparing and SIB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven diagnosis of primary non-small cell lung cancer 3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI within 14 days prior to registration KPS ≥70 Age ≥55 years Informed consent prior to study entry Exclusion Criteria: Patients with leptomeningeal metastases ≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months Contraindication to MRI such as implanted metal devices or foreign bodies Prior radiation therapy (including SRS) to the brain

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>WBRT with hippocampus-sparing and SIB | Radiation: WBRT with hippocampus-sparing and SIB<br>* Radiotherapy could be delivered in 5, 8, or 10 fractions according to participating investigator's choice. The prescribed doses are as below; Fractions 5fxs 8fxs 10fxs Whole brain 20 Gy 24 Gy 25 Gy Gross tumor 30 Gy 40 Gy 40 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial progression free survival | Time from the date of start of radiotherapy to the date of death or intracranial progression | until 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E) | The relative decline in SVLT-E score from baseline to below time frame; ΔSVLT = (SVLTB - SVLTF) ÷ SVLTB, where B=baseline and F=follow-up. | 3,6,12 months | 
| Overall survival | Time from the date of start of radiotherapy to the date of death from any cause | until 12 months | 
| Adverse events | CTCAE v4.03 | 3,6,12 months | 
| Quality of life | EORTC QLQ-C30 and BN20 | 3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hippocampus, radiotherapy