Brain MetastasesSMART-BrainNCT03414944
Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases
A study testing SMART-Brain in people with Brain Metastases, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- SMART-Brain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital
Jin'an, Shandong, 250117
Jiang Aijun, Doctor, +86 0531-67626932, xzjaj@126.com
Yuan Shuanghu, Doctor, +86 0531-67626931, yuanshuanghu@sina.com
About this study
Official title: Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases,A Phase I,One-arm Trial
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.
Read the 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).
- Conditions
- Brain Metastases
- Being tested
- SMART-Brain
- Keywords
- Non-small cell lung cancer, Brain metastases, SIB, hippocampus avoidance, inner ear avoidance
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| SMART-Brain | Experimental | selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance. Receives: Radiation: SMART-Brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Adverse events
Measured: up to 12 months
Secondary outcomes (1)
iPFS
Intracranial progression free survival
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start2 Dec 2016
- Primary completion30 May 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qilu Hospital of Shandong University, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Principal investigator, ShuanghuYuan, Shandong Cancer Hospital and Institute
- Investigators
- Yuan Shuanghu, doctor, Study chair, Shandong cancer hospital and constitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414944
- Sponsor's protocol ID
- CRTOG1602
- Acronym
- SMART-Brain
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16757720Patchell 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.
PubMed 9809728Chang 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.
PubMed 19801201Meyers 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.
PubMed 16525186Meyers 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.
PubMed 14701778Miller 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.
PubMed 27392066Ozdemir 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.
PubMed 27306442Mekhail 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.
PubMed 21584645Jiang 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.
PubMed 30876444
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases,A Phase I,One-arm Trial
- ClinicalTrials.gov ID
- NCT03414944
- Acronym / sponsor ID
- SMART-Brain / CRTOG1602
- Conditions
- Brain Metastases
- Keywords
- Non-small cell lung cancer, Brain metastases, SIB, hippocampus avoidance, inner ear avoidance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qilu Hospital of Shandong University, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMART-Brain | Experimental | Radiation: SMART-Brainselective brain radiotherapy based on SIB and hippocampus, inner ear avoidance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART-BrainPrescription 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. | Radiation | SMART-Brain |
Primary outcome
AE
Time frame: up to 12 months
Adverse events
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Results publication: PubMed 16757720Aoyama 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.
- Results publication: PubMed 9809728Patchell 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.
- Results publication: PubMed 19801201Chang 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.
- Results publication: PubMed 16525186Meyers 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.
- Results publication: PubMed 14701778Meyers 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.
- Results publication: PubMed 27392066Miller 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.
- Results publication: PubMed 27306442Ozdemir 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.
- Results publication: PubMed 21584645Mekhail 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.
- Derived from this study: PubMed 30876444Jiang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Shuanghu, doctor study chair
Shandong cancer hospital and constitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART-Brain in people with Brain Metastases, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Aijiang, doctor (+860531-67626932, xzjaj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03414944, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.