NCT03414944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

January 12, 2018

Last Update Submit

January 29, 2018

Conditions

Brain Metastases

Keywords

Non-small cell lung cancerBrain metastasesSIBhippocampus avoidanceinner ear avoidance

Outcome Measures

Primary Outcomes (1)

  • AE

    Adverse events

    up to 12 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

SMART-Brain

EXPERIMENTAL

selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance.

Radiation: SMART-Brain

Interventions

SMART-BrainRADIATION

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.

SMART-Brain

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Cancer Hospital

Jin'an, Shandong, 250117, China

RECRUITING

Related Publications (9)

  • Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.

    PMID: 16757720RESULT

  • Patchell RA, Tibbs PA, Regine WF, Dempsey RJ, Mohiuddin M, Kryscio RJ, Markesbery WR, Foon KA, Young B. Postoperative radiotherapy in the treatment of single metastases to the brain: a randomized trial. JAMA. 1998 Nov 4;280(17):1485-9. doi: 10.1001/jama.280.17.1485.

    PMID: 9809728RESULT

  • Chang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2.

    PMID: 19801201RESULT

  • Meyers CA, Brown PD. Role and relevance of neurocognitive assessment in clinical trials of patients with CNS tumors. J Clin Oncol. 2006 Mar 10;24(8):1305-9. doi: 10.1200/JCO.2005.04.6086.

    PMID: 16525186RESULT

  • Meyers CA, Smith JA, Bezjak A, Mehta MP, Liebmann J, Illidge T, Kunkler I, Caudrelier JM, Eisenberg PD, Meerwaldt J, Siemers R, Carrie C, Gaspar LE, Curran W, Phan SC, Miller RA, Renschler MF. Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol. 2004 Jan 1;22(1):157-65. doi: 10.1200/JCO.2004.05.128.

    PMID: 14701778RESULT

  • Miller JA, Kotecha R, Suh JH. Comparative effectiveness of stereotactic radiosurgery versus whole-brain radiation therapy for patients with brain metastases from breast or non-small cell lung cancer. Cancer. 2016 Oct 15;122(20):3243-3244. doi: 10.1002/cncr.30188. Epub 2016 Jul 8. No abstract available.

    PMID: 27392066RESULT

  • Ozdemir Y, Yildirim BA, Topkan E. Whole brain radiotherapy in management of non-small-cell lung carcinoma associated leptomeningeal carcinomatosis: evaluation of prognostic factors. J Neurooncol. 2016 Sep;129(2):329-35. doi: 10.1007/s11060-016-2179-9. Epub 2016 Jun 15.

    PMID: 27306442RESULT

  • Mekhail T, Sombeck M, Sollaccio R. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. Curr Oncol Rep. 2011 Aug;13(4):255-8. doi: 10.1007/s11912-011-0180-1. No abstract available.

    PMID: 21584645RESULT

  • Jiang A, Sun W, Zhao F, Wu Z, Shang D, Yu Q, Wang S, Zhu J, Yang F, Yuan S. Dosimetric evaluation of four whole brain radiation therapy approaches with hippocampus and inner ear avoidance and simultaneous integrated boost for limited brain metastases. Radiat Oncol. 2019 Mar 15;14(1):46. doi: 10.1186/s13014-019-1255-7.

    PMID: 30876444DERIVED

MeSH Terms

Conditions

Brain NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yuan Shuanghu, doctor

    Shandong cancer hospital and constitute

    STUDY CHAIR

Central Study Contacts

Jiang Aijiang, doctor

CONTACT

+860531-67626932xzjaj@126.com

Yuan Shuanghu, doctor

CONTACT

+86 0531-67626931yuanshuanghu@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of of Radiation Oncology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 30, 2018

Study Start

December 2, 2016

Primary Completion

May 30, 2018

Study Completion

September 30, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

CN(1)