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| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2008 |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Meets one of the following criteria according to the RTOG recursive partitioning analysis (RPA) classification:
Class I
Class II
KPS 70-100% AND meets at least 1 of the following criteria:
Class III
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |
| Principal Investigator: | Kevin Camphausen, MD | NCI - Radiation Oncology Branch; ROB |
More Information
| 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 |
|
cognitive/functional effects psychosocial effects of cancer and its treatment tumors metastatic to brain unspecified adult solid tumor, protocol specific |
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |