Phase 2
N=113
Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Cognitive/Functional Effects · Metastatic Cancer · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT01227954 ↗Enrolled (actual)
113
Serious AEs
13.5%
Results posted
Sep 2017
Primary outcome: Primary: Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) — 7.0 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- intensity-modulated radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) |
7.0 | <0.001 sig |
| SECONDARY Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT) |
18.0 | — |
| SECONDARY Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT) |
-8 | — |
| SECONDARY Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) |
121.25; 111.94; 115; 126.22 | <0.0001 sig |
| SECONDARY Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL) |
20; 20; 20; 20 | <0.0001 sig |
| SECONDARY Overall Survival |
6.8 | — |
| SECONDARY Progression-free Survival |
5.9 | — |
| SECONDARY The Frequency of Patients With Grade 3 and Higher Adverse Events (AE) Related to Treatment |
2 | — |
| SECONDARY ApoE4 Genotype and Other Potentially Predictive Biomarkers of Cognitive Function |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01227954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.