Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery
NCT ID: NCT01417507
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
82 participants
OBSERVATIONAL
2011-10-31
2014-12-31
Brief Summary
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Detailed Description
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I. To determine if there is difference in the average changes of neurocognitive function (NCF) scores from baseline to the time of radiologic tumor progression or up to 5 years (whichever occurs first), between radiologically progressed and non-progressed patients.
SECONDARY OBJECTIVES:
I. To determine if there is difference in the time to neurocognitive decline, as defined by the Reliable Change Index - Within subjects Standard Deviation (RCI-WSD), between radiologically progressed and non-progressed patients.
II. To evaluate NCF during the postoperative observational period of progression-free survival (PFS) and after radiological progression for a total time on study of 5 years.
III. To determine if the changes in cognitive functioning are an early warning biomarker for radiological progression.
IV. To explore the effect of salvage therapy on cognitive outcomes in patients who progress during the study period for up to 5 years.
V. To evaluate quality-of-life (QOL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QOL-30 and QOL brain module (BCN20) and health utilities as measured by the European Quality of Life-5 Dimensions (EQ-5D), for a total time on study of 5 years.
VI. To evaluate seizure control for a total time on study of 5 years. VII. To evaluate molecular correlates of QOL, NCF, seizure control, and PFS. VIII. To characterize aberrant molecular pathways in low-grade gliomas (LGGs) and test the hypothesis that activation of signaling pathways will predict worse PFS and overall survival (OS).
IX. To explore the relationship between change in cognitive function and symptomatic progression (defined as worsening seizures or new or progressive neurologic deficits) or clinical progression (defined as initiation of treatment interventions such as radiotherapy, chemotherapy, or additional surgery).
OUTLINE:
Patients undergo neurocognitive assessment using the CogState Test battery (the Detection Test (DET), the Identification Test (IDN), the One Card Learning Test (OCLT), and the Groton Maze Learning Test (GMLT)) at baseline\* and at 12, 24, 36, 42, 48, 54, and 60 months. Patients also complete the EORTC Quality of Life Questionnaire-Core 30 (QOL-30), the Brain Cancer Module-20 (BCM20), and the European Quality of Life-5 Dimensions (EQ-5D) questionnaires at baseline\*, at 12, 24, 36, 48, and 60 months afterwards, and before undergoing any further treatment. Patients are instructed to complete a seizure and medication diary during study.
Patients undergo MRI scans at baseline\*, at 12, 24, 36, 48, and 60 months, and at the time of radiological, clinical, or neurological failure.
NOTE: \* 12 weeks after surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Supportive care (neurocognitive assessment and MRI)
Patients undergo neurocognitive assessment using the CogState Test battery (the DET, the IDN, the OCLT, and the GMLT) at baseline\* and at 12, 24, 36, 42, 48, 54, and 60 months. Patients also complete the EORTC QOL-30, the BCM20, and the EQ-5D questionnaires at baseline\*, at 12, 24, 36, 48, and 60 months afterwards, and before undergoing any further treatment. Patients are instructed to complete a seizure and medication diary during study.
Patients undergo MRI scans at baseline\*, at 12, 24, 36, 48, and 60 months, and at the time of radiological, clinical, or neurological failure.
cognitive assessment
Undergo neurocognitive assessment
magnetic resonance imaging
Undergo MRI
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
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cognitive assessment
Undergo neurocognitive assessment
magnetic resonance imaging
Undergo MRI
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No multifocal disease, based upon the following minimum diagnostic work-up:
* History/physical examination, including neurologic examination, within 84 days prior to step 2 registration
* Brain MRI with and without contrast within 84 days prior to Step 2 registration (Note: MRI 70 days after surgery is preferred and highly encouraged)
* The patient must be within one of the following categories:
* Maximal safe resection with minimal residual disease defined as follows:
* Removal of T2/fluid-attenuated inversion recovery (FLAIR) abnormalities thought to be primarily tumor, with a residual ≤ 2 cm maximal tumor diameter/T2 FLAIR abnormality on MRI to be done within 84 days post-operatively
* If there is \> 2 cm post-operative residual T2/FLAIR abnormality and the neurosurgeon believes this represents edema and not primarily tumor, the neurosurgeon is encouraged to repeat imaging within the allowed study period (up to 84 days post-operatively) to confirm resolution of edema
* MRI at the time of enrollment must document a ≤ 2 cm residual maximal tumor diameter/T2 FLAIR abnormality
* Patients who required a second surgery to obtain a maximal safe resection will be eligible if the second surgery is performed within 84 days of the initial diagnostic procedure
* Age \< 40 (any extent of resection)
* Age \< 50 and preoperative tumor diameter \< 4 cm (any extent of resection)
* Karnofsky performance status ≥ 80%
* No prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
* Must be able to undergo MRI of the brain with gadolinium
* No plans for adjuvant radiotherapy or chemotherapy after surgery
* No more than 84 days (12 weeks) since prior surgery
* No brain tumor recurrence
* No prior brain tumor surgery, radiation therapy and/or chemotherapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Ali Choucair
Role: PRINCIPAL_INVESTIGATOR
Radiation Therapy Oncology Group
Locations
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The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Providence Hospital
Mobile, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Florida Hospital
Orlando, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Hawaii
Honolulu, Hawaii, United States
Hawaii Medical Center East
Honolulu, Hawaii, United States
Leeward Radiation Oncology Center
‘Ewa Beach, Hawaii, United States
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, United States
Covenant Medical Center
Waterloo, Iowa, United States
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, United States
Norton Suburban Hospital
Louisville, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Barnes West County Hospital
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Mary's Hospital
Green Bay, Wisconsin, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
London Regional Cancer Program
London, Ontario, Canada
McGill University Department of Oncology
Montreal, Quebec, Canada
Countries
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Other Identifiers
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NCI-2011-02982
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000708271
Identifier Type: -
Identifier Source: secondary_id
RTOG 0925
Identifier Type: -
Identifier Source: org_study_id
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