Clinical trial · Interventional
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Brain | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Assessment | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (SRS/SBRT, neurocognitive testing)
- description
- Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
- interventionNames
- Procedure: Cognitive Assessment
- Radiation: Stereotactic Radiosurgery
- Radiation: Stereotactic Body Radiation Therapy
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Neurocognitive function as measured by neurocognitive decline on a battery of tests
- timeFrame
- At 4 months
- description
- The proportion of patients with neurocognitive decline at 4 months post stereotactic radiosurgery (SRS) treatment in each group will be estimated using the sample proportion with the corresponding two-sided 95% confidence interval. The determination of neurocognitive decline will be based on a battery of tests: Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven solid tumor malignancy (except for small cell lung cancer \[SCLC\], germ cell tumor) * Karnofsky performance status \>= 60 * 1 to 10 brain metastases (mets) (no more than two lesions and/or cavities \>= 3 cm in maximum diameter) * Maximum diameter of brain metastasis or resection cavity is 6 cm * Serum creatinine =\< 3 mg/dL and creatinine clearance \>= 30 ml/min * Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol * Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose * Patient able to provide his/her own written informed consent and speak English Exclusion Criteria: * Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor * Prior brain surgery =\< 14 days prior to enrollment * Planned chemotherapy during radiosurgery * Leptomeningeal metastases * Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months * Pregnant women
References
Publications (0)
Data not yet available