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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)
This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.
In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Brain Radiation | Active Comparator |
|
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| Stereotactic Radiation (SRS) | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole brain radiation | Radiation | Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Survey (symptoms and interference) | Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Clinical Parameter | Through study completion, an average of 1 year |
| Neurologic survival | Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayal Aizer, MD MHS | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41712219 | Derived | Aizer AA, Shin KY, Catalano PJ, Ricca I, Johnson M, Benham G, Roper K, Spicer B, Mann E, Nosker J, Parsons MW, Mendu ML, Hepel J, Chipidza F, Krishnan M, Shi DD, Lamba N, Pashtan I, Peng L, Alexander B, Brown PD, Wen PY, Haas-Kogan DA, Rahman R, Tanguturi S. Treatment for Brain Metastases With Stereotactic Radiation vs Hippocampal-Avoidance Whole Brain Radiation: A Randomized Clinical Trial. JAMA. 2026 Apr 7;335(13):1127-1136. doi: 10.1001/jama.2026.0076. |
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| Stereotactic radiation (SRS) | Radiation | Focused radiation to each individual brain metastasis without treatment of the remainder of the brain. |
|
| Through study completion, an average of 1 year |
| Incidence and time to detection of new brain metastases | Radiographic assessment of first appearance of new brain metastases | Through study completion, an average of 1 year |
| Incidence and time to local recurrence of treated brain tumor(s) | Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation | Through study completion, an average of 1 year |
| Incidence and time to development of radiation necrosis | Radiographic assessment of first appearance of radiation necrosis | Through study completion, an average of 1 year |
| Incidence and time to development of leptomeningeal disease | Radiographic assessment of first appearance of leptomeningeal disease | Through study completion, an average of 1 year |
| Incidence and time to salvage craniotomy | Clinical assessment of first use of neurosurgical resection as salvage therapy | Through study completion, an average of 1 year |
| Incidence and time to additional radiotherapeutic treatments | Clinical assessment of first use of salvage brain-directed radiation | Through study completion, an average of 1 year |
| 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 | Through study completion, an average of 1 year |
| Incidence and time to neurocognitive decline | Scale | 1 year |
| Performance status | Questionnaire - Karnofsky performance status | Through study completion, an average of 1 year |
| Boston |
| Massachusetts |
| 02116 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2026 | Apr 9, 2026 | 12 | ||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D001943 | Breast Neoplasms |
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001941 | Breast Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D013097 | Spermine Synthase |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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