Brain MetastasesNCT03391362
Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases
A study testing Stereotactic Radiation in people with Brain Metastases and Small Cell Lung Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Small Cell Lung Cancer
- What is being tested?
- Stereotactic Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible. Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study.
- 1-10 definitive intracranial lesions must be present on MRI of the brain.
- Age >=18 years at diagnosis of brain metastases.
Who cannot join
- Participants who have undergone prior radiation for brain metastases.
- Participants who have received prophylactic cranial radiation for prevention of brain metastases
- Participants who cannot receive gadolinium
- Participants with stage IV-V chronic kidney disease or end stage renal disease
- Participants with widespread, definitive leptomeningeal disease
- Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
- Participants with >6 definitive lesions consistent with brain metastases
- Participants with inadequate mental capacity to complete quality of life questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Single Arm, Phase II Trial
This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases.
The intervention involved in this study is:
-Stereotactic (focused, pinpoint) radiation
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment, in this case stereotactic radiation, to learn whether this treatment works in treating a specific disease. "Investigational" means that the treatment is being studied.
In patients with a limited number of brain metastases (spread of a cancer that started outside of the brain to the brain itself) the standard radiation option is stereotactic radiation, which involves using a high dose of radiation that only targets the specific metastases that are visible on imaging of the brain, not the whole brain itself. However, studies evaluating the role of stereotactic radiation to treat brain metastases generally excluded patients with small cell lung cancer. Therefore, among patients with small cell lung cancer and brain metastases, the typical treatment that has been offered is whole brain radiation. However, whole brain radiation has deleterious associated side effects including significant fatigue and permanent memory/attention problems. The investigators are studying whether stereotactic radiation can be effectively utilized for patients with small cell lung cancer and brain metastases in order to avoid such side effects.
- Conditions
- Brain Metastases, Small Cell Lung Cancer
- Being tested
- Stereotactic Radiation
- Keywords
- Small Cell Lung Cancer, Brain Metastases, Brain metastasis, Lung cancer, Stereotactic radiation, Stereotactic radiosurgery, SRS, Stereotactic, Radiation, Quality of life, Neurocognitive, Neurocognition
- Medical subject headings
- Brain Neoplasms, Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiationRadiation
Stereotactic radiation involves using a high dose of radiation that only targets the specific metastases
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiation | Experimental | * Stereotactic radiation will begin within 14 days of the MRI used for radiation planning
* Lesions <2 cm in maximum diameter will be treated with stereotactic radiosurgery, generally 20 Gy in 1 fraction
* Lesions between 2.0 and 3.0 cm in maximum diameter will generally be treated to 18 Gy in 1 fraction
* Lesions >3 cm will be generally be treated with stereotactic radiotherapy to 30 Gy in 5 fractions Receives: Radiation: Stereotactic Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic Mortality
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic progressive disease).
Measured: 12 months
Secondary outcomes (18)
All-cause Mortality
Death from any cause cumulative incidence estimate assessed at 1 year and 2 year
Measured: Until death or loss to follow up, up to 24 months
Quality of Life as Assessed by Patient Questionnaire
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Measured: Until death or loss to follow up, up to 24 months
Neurocognitive Function: Verbal Learning and Memory
Hopkins Verbal Learning Test -Revised (HVLT-R). Scores are transformed into Z scores.
Measured: 12 months
Neurocognitive Function: Visual Attention and Task Switching
Trail Making Test Part A and B (TMT). Scores are transformed into Z scores.
Measured: 12 months
Neurocognitive Function: Verbal Fluency
Controlled Oral Word Association Test (COWAT). Scores are transformed into Z scores.
Measured: 12 months
Neurocognitive Function: Cognitive Impairment
Mini Mental Status Examination (MMSE). Scored 0 to 30. Higher scores indicate better cognitive function
Measured: 12 months
Ability to Complete Activities of Daily Living
Questionnaire - EQ-5D. A patient reported quality of life questionnaire
Measured: Until death or loss to follow up, up to 24 months
Performance Status
Karnofsky performance status. Scale ranges from 0 to 100, with higher scores indicating better function.
Measured: Until death or loss to follow up, up to 24 months
One and Two Year Incidence of New Brain Metastases
1 and 2 year estimates of first appearance of new brain metastases (on radiographic assessment)
Measured: Until death or loss to follow up, up to 24 months
Incidence of Existing Brain Metastases
Per patient radiographic assessment of first event of local recurrence in the brain metastases treated with radiation on trial. One- and 2-Year estimates.
Measured: Until death or loss to follow up, up to 24 months
Incidence of Development of Radiographic Radiation Necrosis
Per patient radiographic assessment of first event of radiation necrosis in the brain metastases treated with radiation on trial. One- and 2-Year cumulative incidence estimates.
Measured: Until death or loss to follow up, up to 24 months
Incidence of Development of Leptomeningeal Disease
Per patient radiographic assessment of first event of leptomeningeal disease. One- and 2-Year estimates.
Measured: Until death or loss to follow up, up to 24 months
Incidence of Salvage Craniotomy
Per patient clinical assessment of first use of neurosurgical resection / craniotomy as salvage therapy in metastases treated with radiation on trial. One- and 2-Year estimates.
Measured: Until death or loss to follow up, up to 24 months
Incidence of Additional CNS-directed Radiotherapeutic Treatments (Stereotactic Radiation) After the Initial Course
Per patient clinical assessment of first use of salvage brain-directed stereotactic radiation. 1- and 2-Year estimates.
Measured: Until death or loss to follow up, up to 24 months
Incidence of Seizures
Per patient clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review. 1 and 2-Year estimates.
Measured: Until death or loss to follow up, up to 24 months
Incidence of Symptomatic Radiation Necrosis
Per patient assessment of first event of symptomatic radiation necrosis in the brain metastases treated with radiation on trial. 1- and 2-Year estimates.
Measured: Until death or loss to follow up, up to 24 months
Incidence of Neurologic Death at 2 Years
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic progressive disease).
Measured: 2-years
Incidence of Additional CNS-directed Radiotherapeutic Treatments (Whole Brain Radiation) After the Initial Course
Per patient clinical assessment of first use of salvage whole brain radiation. One- and 2-Year estimates.
Measured: Until death or loss to follow up, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start23 Feb 2018
- Primary completion10 Apr 2024
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Ayal A. Aizer, MD, Brigham and Women's Hospital
- Investigators
- Ayal A Aizer, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391362
- Sponsor's protocol ID
- 17-550
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2017
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Aizer AA, Tanguturi SK, Shi DD, Catalano PJ, Shin KY, Ricca I, Johnson M, Benham G, Kozono DE, Mak RH, Hertan L, Chipidza F, Krishnan M, Pashtan I, Peng L, Qian JM, Shiloh RY, Cagney DN, Sands J, Brown PD, Wen PY, Haas-Kogan DA, Rahman R. Stereotactic Radiosurgery in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Multi-Institutional, Phase II, Prospective Clinical Trial. J Clin Oncol. 2025 Sep 20;43(27):2986-2997. doi: 10.1200/JCO-25-00056. Epub 2025 Jul 11.
PubMed 40644657
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Single Arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT03391362
- Acronym / sponsor ID
- 17-550
- Conditions
- Brain Metastases, Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer, Brain Metastases, Brain metastasis, Lung cancer, Stereotactic radiation, Stereotactic radiosurgery, SRS, Stereotactic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases.
The intervention involved in this study is:
-Stereotactic (focused, pinpoint) radiation
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment, in this case stereotactic radiation, to learn whether this treatment works in treating a specific disease. "Investigational" means that the treatment is being studied.
In patients with a limited number of brain metastases (spread of a cancer that started outside of the brain to the brain itself) the standard radiation option is stereotactic radiation, which involves using a high dose of radiation that only targets the specific metastases that are visible on imaging of the brain, not the whole brain itself. However, studies evaluating the role of stereotactic radiation to treat brain metastases generally excluded patients with small cell lung cancer. Therefore, among patients with small cell lung cancer and brain metastases, the typical treatment that has been offered is whole brain radiation. However, whole brain radiation has deleterious associated side effects including significant fatigue and permanent memory/attention problems. The investigators are studying whether stereotactic radiation can be effectively utilized for patients with small cell lung cancer and brain metastases in order to avoid such side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiation | Experimental | Radiation: Stereotactic Radiation* Stereotactic radiation will begin within 14 days of the MRI used for radiation planning * Lesions <2 cm in maximum diameter will be treated with stereotactic radiosurgery, generally 20 Gy in 1 fraction * Lesions between 2.0 and 3.0 cm in maximum diameter will generally be treated to 18 Gy in 1 fraction * Lesions >3 cm will be generally be treated with stereotactic radiotherapy to 30 Gy in 5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible. Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study.
- 1-10 definitive intracranial lesions must be present on MRI of the brain.
- Age >=18 years at diagnosis of brain metastases.
Key exclusion criteria (8 listed)
- Participants who have undergone prior radiation for brain metastases.
- Participants who have received prophylactic cranial radiation for prevention of brain metastases
- Participants who cannot receive gadolinium
- Participants with stage IV-V chronic kidney disease or end stage renal disease
- Participants with widespread, definitive leptomeningeal disease
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 |
|---|---|---|
| Stereotactic RadiationStereotactic radiation involves using a high dose of radiation that only targets the specific metastases | Radiation | Stereotactic Radiation |
Primary outcome
Neurologic Mortality
Time frame: 12 months
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic progressive disease).
18 secondary outcomes
All-cause Mortality
Time frame: Until death or loss to follow up, up to 24 months
Quality of Life as Assessed by Patient Questionnaire
Time frame: Until death or loss to follow up, up to 24 months
Neurocognitive Function: Verbal Learning and Memory
Time frame: 12 months
Neurocognitive Function: Visual Attention and Task Switching
Time frame: 12 months
Neurocognitive Function: Verbal Fluency
Time frame: 12 months
Neurocognitive Function: Cognitive Impairment
Time frame: 12 months
Ability to Complete Activities of Daily Living
Time frame: Until death or loss to follow up, up to 24 months
Performance Status
Time frame: Until death or loss to follow up, up to 24 months
One and Two Year Incidence of New Brain Metastases
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Existing Brain Metastases
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Development of Radiographic Radiation Necrosis
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Development of Leptomeningeal Disease
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Salvage Craniotomy
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Additional CNS-directed Radiotherapeutic Treatments (Stereotactic Radiation) After the Initial Course
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Seizures
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Symptomatic Radiation Necrosis
Time frame: Until death or loss to follow up, up to 24 months
Incidence of Neurologic Death at 2 Years
Time frame: 2-years
Incidence of Additional CNS-directed Radiotherapeutic Treatments (Whole Brain Radiation) After the Initial Course
Time frame: Until death or loss to follow up, up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40644657Aizer AA, Tanguturi SK, Shi DD, Catalano PJ, Shin KY, Ricca I, Johnson M, Benham G, Kozono DE, Mak RH, Hertan L, Chipidza F, Krishnan M, Pashtan I, Peng L, Qian JM, Shiloh RY, Cagney DN, Sands J, Brown PD, Wen PY, Haas-Kogan DA, Rahman R. Stereotactic Radiosurgery in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Multi-Institutional, Phase II, Prospective Clinical Trial. J Clin Oncol. 2025 Sep 20;43(27):2986-2997. doi: 10.1200/JCO-25-00056. Epub 2025 Jul 11.
- Individual participant dataSharing planned: No
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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.
Ayal A Aizer, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiation in people with Brain Metastases and Small Cell Lung Cancer, run by Brigham and Women's Hospital at 1 site in United States.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic Mortality (time frame: 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 NCT03391362, which also lists 1 linked publication.
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 29 Sep 2026.