Clinical trial · Interventional
Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
NCT01227954CI-TRIAL-00029682completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- WBRT with Hippocampal Avoidance
- description
- Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
- interventionNames
- Radiation: intensity-modulated radiation therapy
Primary outcomes (1)
- measure
- Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
- timeFrame
- Baseline and 4 months from start of treatment
- description
- Change in Hopkins Verbal Learning Test-Revised delayed recall (HVLT\_R DR) score from baseline to 4 months after the start of treatment calculated as (baseline score - 4 month score)/ baseline score. A positive change indicates a decline in function. The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms, helping to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. Delayed recall involves recalling a list of 12 targets after a 20-minute delay. The score is the sum of the number of targets correctly recalled. Percent change calculated as 100\*\[(baseline score - 4 month score)/ baseline score\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Histologically or cytologically confirmed non-hematopoietic malignancy within the past 5 years * If histologic proof of malignancy is from \> 5 years ago, then a more recent pathological confirmation is required (e.g., from systemic metastatic or brain metastasis) * Patients with metastasis of unknown primary tumor are permitted * Measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast-enhanced MRI obtained within the past 30 days * Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection * These treatment options are allowed only at relapse * Patients who have brain metastases at initial presentation allowed and do not need to demonstrate 3 months of stable scans * At least 1 week since open biopsy * Karnofsky performance status 70-100% * Fertile patients must use effective contraception * Negative pregnancy test 2 weeks or less prior to study entry * Patients must be English proficient, with patients who speak English as a second language eligible EXCLUSION CRITERIA: * Small cell lung cancer or germ cell malignancy * Leptomeningeal metastases * Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of extracranial metastases * Radiologic evidence of hydrocephalus * Serum creatinine \> 1.4 mg/dL within 30 days prior to study entry * Pregnant or nursing * Contraindication to MRI imaging such as implanted metal devices or foreign bodies or severe claustrophobia * Severe, active co-morbidity including any of the following: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction within the past 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy * Uncontrolled, clinically significant cardiac arrhythmias * Prior radiotherapy to the brain * Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7 days
References
Publications (1)
- RESULTGondi V, Pugh SL, Tome WA, Caine C, Corn B, Kanner A, Rowley H, Kundapur V, DeNittis A, Greenspoon JN, Konski AA, Bauman GS, Shah S, Shi W, Wendland M, Kachnic L, Mehta MP. Preservation of memory with conformal avoidance of the hippocampal neural stem-cell compartment during whole-brain radiotherapy for brain metastases (RTOG 0933): a phase II multi-institutional trial. J Clin Oncol. 2014 Dec 1;32(34):3810-6. doi: 10.1200/JCO.2014.57.2909. Epub 2014 Oct 27. PMID 25349290