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

NCT ID: NCT03366376

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2019-12-01

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.

Detailed Description

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Conditions

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Brain Metastases

Keywords

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hippocampus radiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

WBRT with hippocampus-sparing and SIB

Group Type EXPERIMENTAL

WBRT with hippocampus-sparing and SIB

Intervention Type RADIATION

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

Interventions

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WBRT 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

Intervention Type RADIATION

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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Radiation Oncology Group

UNKNOWN

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Chan Ahn, MD, PhD

Role: CONTACT

Phone: +82-2-3410-2602

Email: [email protected]

Facility Contacts

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Yong Chan Ahn, MD,PhD

Role: primary

Other Identifiers

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2017-08-070

Identifier Type: -

Identifier Source: org_study_id