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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiation | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiation | Radiation | Stereotactic radiation involves using a high dose of radiation that only targets the specific metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death due to progressive neurologic disease | Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Clinical parameter | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayal A Aizer, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40644657 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2026 | Apr 9, 2026 | 9 | ||
| May 15, 2026 |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Until death or loss to follow up, up to 24 months |
| Neurocognitive function: Verbal learning and memory | Hopkins Verbal Learning Test -Revised (HVLT-R) | 12 months |
| Neurocognitive function: Visual attention and task switching | Trail Making Test Part A and B (TMT) | 12 months |
| Neurocognitive function: Verbal fluency | Controlled Oral Word Association Test (COWAT) | 12 months |
| Neurocognitive function: Cognitive impairment | Mini Mental Status Examination (MMSE) | 12 months |
| Ability to complete activities of daily living | Questionnaire - EQ-5D | Until death or loss to follow up, up to 24 months |
| Performance status | Karnofsky performance status | Until death or loss to follow up, up to 24 months |
| Incidence and time to detection of new brain metastases | Radiographic assessment of first appearance of new brain metastases | Until death or loss to follow up, up to 24 months |
| Incidence and time to local recurrence of existing brain metastases | Radiographic assessment of first local recurrence in the 1-6 brain metastases that were initially treated with radiation | Until death or loss to follow up, up to 24 months |
| Incidence and time to development of radiation necrosis | Radiographic assessment of first appearance of radiation necrosis | Until death or loss to follow up, up to 24 months |
| Incidence and time to development of leptomeningeal disease | Radiographic assessment of first appearance of leptomeningeal disease | Until death or loss to follow up, up to 24 months |
| Incidence and time to progressive intracranial disease | Radiographic assessment of first appearance of progressive intracranial disease | Until death or loss to follow up, up to 24 months |
| Incidence and time to salvage craniotomy | Clinical assessment of first use of neurosurgical resection as salvage therapy | Until death or loss to follow up, up to 24 months |
| Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course | Clinical assessment of first use of salvage brain-directed radiation | Until death or loss to follow up, up to 24 months |
| Incidence and time to the development of seizures | Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review | Until death or loss to follow up, up to 24 months |
| Jun 11, 2026 |
| 10 |
| Jun 16, 2026 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |