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

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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Metastases
• Intervention / Treatment: Radiation: WBRT with hippocampus-sparing and SIB

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Yong Chan Ahn, MD,PhD; Phone Number: +82-2-3410-2602; Email: ycahn.ahn@samsung.com
    • Sub-Investigator: Jae Myoung Noh, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; WBRT with hippocampus-sparing and SIB	Radiation: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Korean Radiation Oncology Group

Study record dates

Study Major Dates

• Study Start (Anticipated): December 11, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 3, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: radiotherapy; hippocampus
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: 2017-08-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No