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Neuropsychological Measures in Patients Undergoing Radiation Therapy for Brain Metastases
This study is currently recruiting participants.
Verified September 2011 by National Institutes of Health Clinical Center (CC)

First Received on October 8, 2008.   Last Updated on September 29, 2011   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00769444
  Purpose

RATIONALE: Learning about the neuropsychological function in patients undergoing radiation therapy for brain metastases may help doctors learn more about the long-term effects of radiation therapy and help plan the best treatment.

PURPOSE: This clinical trial is studying neuropsychological measures in patients undergoing radiation therapy for brain metastases.


Condition Intervention
Cognitive/Functional Effects
Metastatic Cancer
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: cognitive assessment
Procedure: psychosocial assessment and care
Radiation: radiation therapy
Radiation: stereotactic radiosurgery

Study Type: Observational
Official Title: A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Hopkins Verbal Learning Test Recall T-score [ Designated as safety issue: No ]
  • WAIS-III Digit Span Subtest Scaled Score [ Designated as safety issue: No ]
  • WAIS-III Symbol Search Subtest Scaled Score [ Designated as safety issue: No ]
  • Ruff 2 and 7 Selective Attention Test Total Accuracy T-score [ Designated as safety issue: No ]
  • Trailmaking Test Part B Speed Z-score [ Designated as safety issue: No ]
  • Grooved Pegboard Test Dominant Hand Z-score [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hopkins Verbal Learning Test Delayed Recall T-score [ Designated as safety issue: No ]
  • Ruff 2 and 7 Selective Attention Test Total Speed T-score [ Designated as safety issue: No ]
  • Trailmaking Test Part A Speed Z-score [ Designated as safety issue: No ]
  • Grooved Pegboard Test Non-dominant Hand Z-score [ Designated as safety issue: No ]
  • COWA Total Score [ Designated as safety issue: No ]
  • NART-35 Total Score [ Designated as safety issue: No ]
  • Barthel Index Total Score [ Designated as safety issue: No ]
  • FACT-Br Domain and Total Scores [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Detailed Description:

OBJECTIVES:

Primary

  • To identify neuropsychological test scores that detect significant change in neuropsychological functioning in patients undergoing radiotherapy for brain metastases.
  • To examine the relationship between neuropsychological function and survival of these patients.

Secondary

  • To further examine whether other measures from the following battery of tests detect significant change in neuropsychological function or predict prognosis in these patients: North American Adult Reading Test-Short Form (NART-35), Hopkins Verbal Learning Test (HVLT), WAIS-III Digit Span Subtest, WAIS-III Symbol Search Subtest, Ruff 2 and 7 Selective Attention Test, Trail Making Test Part A and B (TMT), Controlled Oral Word Association Test (COWAT), Grooved Pegboard, Barthel Index, and the Functional Assessment of Cancer Therapy-Brain (FACT-Br).
  • To examine the relationship between the RTOG recursive partitioning analysis (RPA) classification for brain metastasis survival and baseline neuropsychological functioning in these patients.
  • To examine the strengths and weaknesses in neuropsychological functioning of these patients after radiotherapy.
  • To explore the neuropsychological functioning of patients treated with different therapies (e.g., chemotherapy, corticosteroids, or complete surgical resection).
  • To investigate the relationship between neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence in these patients.
  • To investigate the role of biomarkers, including NSE, S100B, MMPs, and VEGF, as potential markers of brain injury and disease progression using serum, plasma, and urine samples from these patients.
  • To gather baseline neuropsychological data for use as a reference in the development of new clinical trials involving this patient population in the Radiation Oncology Branch (ROB).

OUTLINE: Patients are stratified according to RTOG recursive partitioning analysis (RPA) classification.

Patients undergo whole brain radiotherapy once daily 5 days a week for 2 weeks (10 fractions). Some patients may then undergo stereotactic radiosurgery boost.

Patients undergo neuropsychological testing (involving 40 minutes of direct cognitive testing and 15 minutes of questionnaires) at baseline and at 1, 3, 6, 9, and 12 months.

Blood and urine samples are collected periodically for laboratory biomarker studies. Blood samples are analyzed for NSE and S100B by ELISA. Urine samples are analyzed for MMP by ELISA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary malignancy
  • At least one intraparenchymal brain metastasis as identified on brain MRI with IV contrast
  • Meets one of the following criteria according to the RTOG recursive partitioning analysis (RPA) classification:

    • Class I

      • Age 65 and under
      • Controlled primary tumor
      • No extracranial metastases
      • Karnofsky performance status (KPS) 70-100%
    • Class II

      • KPS 70-100% AND meets at least 1 of the following criteria:

        • Uncontrolled or synchronous primary disease
        • Extracranial metastases
        • Over 65 years of age
    • Class III

      • KPS less than 70%
  • No leptomeningeal metastases

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • Able to communicate in English
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No impaired cognition that would preclude giving informed consent
  • No pre-existing or active psychiatric or neurologic impairment (not caused by the brain metastasis), other medical condition, or clinically significant unrelated systemic illness, that in the opinion of the investigator, would preclude study participation
  • No HIV positivity

PRIOR CONCURRENT THERAPY:

  • No treatment for prior brain metastasis
  • No prior cranial radiotherapy
  • More than 14 days since prior investigational drugs for the primary malignancy
  • More than 7 days since prior and no concurrent systemic therapy (e.g., chemotherapy, immunotherapy, or biological therapy)
  • At least 14 days since prior surgery for the current brain metastases
  • No concurrent neurosurgery
  • No concurrent emergent radiotherapy for brain metastases
  • No concurrent investigational drugs
  • Concurrent local therapy (e.g., surgery or radiotherapy) for the primary malignancy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769444

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Kevin Camphausen, MD NCI - Radiation Oncology Branch; ROB
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00769444     History of Changes
Other Study ID Numbers: 080214, CDR0000615194, NCI-08-C-0214
Study First Received: October 8, 2008
Last Updated: September 29, 2011
Health Authority: Unspecified

Keywords provided by National Institutes of Health Clinical Center (CC):
cognitive/functional effects
psychosocial effects of cancer and its treatment
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012