Clinical trial · Interventional
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial
NCT03075072CI-TRIAL-00081861active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiation (SRS) | Radiation | — | UNRESOLVED |
| Whole brain radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Whole Brain Radiation
- description
- * MRI will be performed prior to radiation is administered * A hippocampal sparing approach will be used when possible * Dose will be 30 Gy in 10 fractions
- interventionNames
- Radiation: Whole brain radiation
- type
- EXPERIMENTAL
- label
- Stereotactic Radiation (SRS)
- description
- * MRI will be performed prior to radiation is administered * Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)
- interventionNames
- Radiation: Stereotactic radiation (SRS)
Primary outcomes (1)
- measure
- Change in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible * Five-twenty intracranial lesions must be present on MRI of the brain * Age 18-80 years at diagnosis of brain metastases * Karnofsky performance status of at least 70 Exclusion Criteria: * Participants who have undergone prior radiation for brain metastases. * Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study * Participants who cannot undergo a brain MRI * Participants who cannot receive gadolinium (MRI contrast) * Participants with stage IV-V chronic kidney disease or end stage renal disease * Participants with widespread, definitive leptomeningeal disease * Participants with small cell lung cancer, lymphoma, or myeloma * Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
References
Publications (4)
- RESULTAyal Aizer et al. Stereotactic radiation versus hippocampal avoidance whole brain radiation in patients with 5-20 brain metastases: A multicenter, phase 3 randomized trial.. J Clin Oncol 43, 2011-2011(2025). DOI:10.1200/JCO.2025.43.16_suppl.2011
- RESULTAizer A et al. Multicenter, Phase 3 Randomized Trial of Stereotactic Radiation vs. Hippocampal Avoidance Whole Brain Radiation in Patients with 5-20 Brain Metastases: Recurrence, Salvage Therapy, and Mortality Endpoints International Journal of Radiation Oncology, Biology, Physics, 123, S33-S34
- RESULTMichael Parsons, Kee-Young Shin, Jennifer Nosker, Shyam Tanguturi, Paul Catalano, Daphne Haas-Kogan, Jaroslaw Hepel, Marciana Johnson, Grant Benham, Ivy Ricca, Rifaquatn Rahma, Ayal Aizer, NCOG-20. Stereotactic radiation versus hippocampal avoidant whole brain radiation in patients with 5-20 brain metastases: Cognitive outcomes of 12-month survivors, Neuro-Oncology, Volume 27, Issue Supplement_5, November 2025, Pages v325-v326, https://doi.org/10.1093/neuonc/noaf201.1287
- RESULTAizer 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. PMID 41712219