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

Phase 2

• Conditions: Brain Metastases
• Interventions: Radiation: WBRT with hippocampus-sparing and SIB

• Registration Number: NCT03366376
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-08
• Last Update Posted: 2017-12-08
• Study Start: 2017-12-11
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	WBRT with hippocampus-sparing and SIB	WBRT with hippocampus-sparing and SIB

Primary Outcome Measures

Name	Time	Method
Intracranial progression free survival	until 12 months	Time from the date of start of radiotherapy to the date of death or intracranial progression

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of