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A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases

Phase 2
18 Years
Open (Enrolling)
Cognitive/Functional Effects, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases



- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised
(HVTL-R) at 4 months after hippocampal avoidance during whole-brain radiotherapy
(HA-WBRT) in patients with brain metastasis.


- Evaluate auditory and visual learning and memory, as assessed by 2 CogState tests
(International Shopping List Test and One Card Learning Test), after HA-WBRT in these

- Compare psychometric properties of the 2 CogState tests to the HVLT-R for the
assessment of memory decline after HA-WBRT in these patients.

- Evaluate health-related quality of life [as assessed by the Functional Assessment of
Cancer Therapy with Brain Subscale (FACT-BR) and the Barthel Index of Activities of
Daily Living (ADLs)] after HA-WBRT in these patients.

- Evaluate time to radiographic progression after HA-WBRT in these patients.

- Evaluate overall survival of these patients after HA-WBR.

- Evaluate the adverse events of HA-WBR.

- Evaluate predictive biomarkers of cognitive function.

OUTLINE: This is a multicenter study.

Patients undergo 10 fractions of intensity-modulated whole-brain radiotherapy (WBRT),
avoiding hippocampal (HA) regions, once daily, 5 days a week, for 2-2½ weeks.

Patients neurocognitive functions (delayed recall, auditory and visual learning, and memory)
are evaluated by the Hopkins Verbal Learning Test-Revised (HVTL-R), The One Card Learning
Test (OCLT), and the International Shopping List Test (ISLT) at baseline and periodically
during study.

Patients may undergo serum, plasma, or whole blood collection at baseline and at 4 months
after completion of HA-WBRT for correlative studies.

Patients may complete the Functional Assessment of Cancer Therapy with Brain Subscale
(FACT-BR), and the Barthel Index of Activities of Daily Living (ADLs) quality-of-life
questionnaires at baseline and periodically during study and follow up.

After completion of study therapy, patients are followed up periodically.

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

- 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

- 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


- 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 MR 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Delayed recall at 4 months as measured by the Hopkins Verbal Learning Test-Revised

Outcome Time Frame:

Within 2 weeks prior to treatment, 4 months after HA-WBRT

Safety Issue:


Principal Investigator

Minesh P. Mehta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2011

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cognitive/functional effects
  • tumors metastatic to brain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



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