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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03366376

Acronym

KROG17-06

Enrollment

Registered

2017-12-08

Start date

2017-12-11

Completion date

2019-12-01

Last updated

2017-12-08

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

Conditions

Brain Metastases

Keywords

hippocampus, radiotherapy

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.

Interventions

RADIATIONWBRT with hippocampus-sparing and SIB

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Quality of life	3,6,12 months	EORTC QLQ-C30 and BN20

Countries

South Korea

Contacts

Primary ContactYong Chan Ahn, MD, PhD

ycahn.ahn@samsung.com+82-2-3410-2602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026