Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases

Not Applicable

• Conditions: Brain Metastases
• Interventions: Radiation: SMART-Brain

• Registration Number: NCT03414944
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

Brain metastases are the most common intracranial tumors in adults. Whole-brain radiation therapy (WBI) increases the median survival of patients with brain metastases up to 3-6 months, but WBI can lead to the decline of cognition and quality of life, with short local control time. The use of SIB(simultaneous integrated boost) technology can increase the local control rate. Hippocampus avoidance can effectively reduce the cognitive impairment caused by WBI.This study was designed to evaluate the safety and efficacy of selective brain radiotherapy (EBI)(based on SIB and hippocampus, inner ear avoidance )in NSCLCs with limited brain metastases.

Detailed Description

In this prospective phase 1 study evaluating the safety and efficacy of selective brain radiotherapy in NSCLCs with limited brain metastases, patients will received selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance.

Prescription dose: Gross tumor (PGTV) 40-50 Gy/10 fractions/2 weeks + EBI (PCTV) 30 Gy/10 fractions/2 weeks.

OARs dose limits: Hippocampus D100%≤10Gy, Dmax≤17Gy,Inner ear: Dmean ≤15Gy. All patients were observed and recorded daily for acute radiation impairment during radiotherapy. Follow-up every 2 months will be performed after radiotherapy.

The primary endpoint:Acute and chronic radiation response, QOL in patients, vestibular function,neurocognitive function based on mini-mental state examination(MMSE) questionnaires, hearing.

The secondary endpoint included:objective response rate (ORR);intracranial progression-free survival (iPFS); OS (defined as the time from study beginning to death from any cause).

Study Timeline

• Study Start: 2016-12-02
• Status Verified: 2018-01
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-29
• Last Update Submitted: 2018-01-29
• Study First Posted: 2018-01-30
• Last Update Posted: 2018-01-30
• Primary Completion: 2018-05-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

histologically or cytologically confirmed NSCLC with MRI confirmed new brain metastases a life expectancy of at least 3 months; adequate organ function according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.

Exclusion Criteria

radiologically or pathologically confirmed metastases in the spinal cord or meninges obvious hernia formation risk previously received brain surgery or radiotherapy a history or presence of poorly controlled systemic diseases pregnant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SMART-Brain	SMART-Brain	selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance.

Primary Outcome Measures

Name	Time	Method
AE	up to 12 months	Adverse events

Secondary Outcome Measures

Name	Time	Method
iPFS	From date of treatment begining until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months	Intracranial progression free survival

Trial Locations

Locations (1)

Shandong Cancer Hospital; 🇨🇳 Jin'an, Shandong, China