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Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC (KROG17-06)

Primary Purpose

Brain Metastases

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WBRT with hippocampus-sparing and SIB
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring hippocampus, radiotherapy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

WBRT with hippocampus-sparing and SIB

Outcomes

Primary Outcome Measures

Intracranial progression free survival
Time from the date of start of radiotherapy to the date of death or intracranial progression

Secondary Outcome Measures

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.
Overall survival
Time from the date of start of radiotherapy to the date of death from any cause
Adverse events
CTCAE v4.03
Quality of life
EORTC QLQ-C30 and BN20

Full Information

First Posted
December 3, 2017
Last Updated
December 7, 2017
Sponsor
Samsung Medical Center
Collaborators
Korean Radiation Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT03366376
Brief Title
Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC
Acronym
KROG17-06
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2017 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Korean Radiation Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
hippocampus, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
WBRT with hippocampus-sparing and SIB
Intervention Type
Radiation
Intervention Name(s)
WBRT with hippocampus-sparing and SIB
Intervention Description
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
Primary Outcome Measure Information:
Title
Intracranial progression free survival
Description
Time from the date of start of radiotherapy to the date of death or intracranial progression
Time Frame
until 12 months
Secondary Outcome Measure Information:
Title
Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)
Description
The relative decline in SVLT-E score from baseline to below time frame; ΔSVLT = (SVLTB - SVLTF) ÷ SVLTB, where B=baseline and F=follow-up.
Time Frame
3,6,12 months
Title
Overall survival
Description
Time from the date of start of radiotherapy to the date of death from any cause
Time Frame
until 12 months
Title
Adverse events
Description
CTCAE v4.03
Time Frame
3,6,12 months
Title
Quality of life
Description
EORTC QLQ-C30 and BN20
Time Frame
3,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Chan Ahn, MD, PhD
Phone
+82-2-3410-2602
Email
ycahn.ahn@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Chan Ahn, MD,PhD
Phone
+82-2-3410-2602
Email
ycahn.ahn@samsung.com
First Name & Middle Initial & Last Name & Degree
Jae Myoung Noh, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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