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Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases (SMART-Brain)

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ClinicalTrials.gov Identifier: NCT03414944
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborators:
Shandong Provincial Hospital
Qilu Hospital of Shandong University
The Affiliated Hospital of Xuzhou Medical University
Information provided by (Responsible Party):
ShuanghuYuan, 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.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: SMART-Brain Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases,A Phase I,One-arm Trial
Actual Study Start Date : December 2, 2016
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : September 30, 2018

Arm Intervention/treatment
Experimental: SMART-Brain
selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance.
Radiation: SMART-Brain

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.





Primary Outcome Measures :
  1. AE [ Time Frame: up to 12 months ]
    Adverse events


Secondary Outcome Measures :
  1. iPFS [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414944


Contacts
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Contact: Jiang Aijiang, doctor +860531-67626932 xzjaj@126.com
Contact: Yuan Shuanghu, doctor +86 0531-67626931 yuanshuanghu@sina.com

Locations
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China, Shandong
Shandong Cancer Hospital Recruiting
Jin'an, Shandong, China, 250117
Contact: Jiang Aijun, Doctor    +86 0531-67626932    xzjaj@126.com   
Contact: Yuan Shuanghu, Doctor    +86 0531-67626931    yuanshuanghu@sina.com   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Shandong Provincial Hospital
Qilu Hospital of Shandong University
The Affiliated Hospital of Xuzhou Medical University
Investigators
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Study Chair: Yuan Shuanghu, doctor Shandong cancer hospital and constitute

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ShuanghuYuan, Director, Head of of Radiation Oncology, Principal Investigator, Clinical Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03414944     History of Changes
Other Study ID Numbers: CRTOG1602
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by ShuanghuYuan, Shandong Cancer Hospital and Institute:
Non-small cell lung cancer
Brain metastases
SIB
hippocampus avoidance
inner ear avoidance

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases