Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma
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.
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
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
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).
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.
Observational Model: Cohort, Time Perspective: Prospective
NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)
Each of the battery's tests will be evaluated using the 2-sample t-test with a 2-sided significance level of 0.05 to determine if there is a clinically meaningful difference in the average change of NCF score from baseline to the time of radiologic tumor progression or up to 5 years (whichever occurs first) between radiologically progressed and non-progressed patients. In order to adjust for multiple comparisons and maintain the overall type I error of 0.05, Hochberg's procedure will be applied.
Up to 5 years
Radiation Therapy Oncology Group
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Geisinger Medical Center||Danville, Pennsylvania 17822-0001|
|York Hospital||York, Pennsylvania 17315|
|Community Memorial Hospital||Menomonee Falls, Wisconsin 53051|
|Waukesha Memorial Hospital||Waukesha, Wisconsin 53188|
|Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Piedmont Hospital||Atlanta, Georgia 30309|
|Arizona Oncology Services Foundation||Phoenix, Arizona 85013|
|Leeward Radiation Oncology Center||Ewa Beach, Hawaii 96706|
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|
|Queen's Medical Center||Honolulu, Hawaii 96813|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Providence Hospital||Mobile, Alabama 36608|
|University of Rochester||Rochester, New York 14642|
|Radiation Therapy Oncology Group||Philadelphia, Pennsylvania 19107|
|Huntsman Cancer Institute/University of Utah||Salt Lake City, Utah 84112|
|Florida Hospital||Orlando, Florida 32803|
|University of Cincinnati||Cincinnati, Ohio 45267-0502|
|Hawaii Medical Center East||Honolulu, Hawaii 96817|
|Penn State Milton S Hershey Medical Center||Hershey, Pennsylvania 17033|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|University of Hawaii||Honolulu, Hawaii 96813|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Covenant Medical Center||Waterloo, Iowa 50702|
|Billings Clinic||Billings, Montana 59107-7000|
|Saint Vincent Hospital||Green Bay, Wisconsin 54301|
|Saint Mary's Hospital||Green Bay, Wisconsin 54303|
|The Nebraska Medical Center||Omaha, Nebraska 68198|
|Norton Health Care Pavilion - Downtown||Louisville, Kentucky 40202|
|Norton Suburban Hospital||Louisville, Kentucky 40207|
|Adams Cancer Center||Gettysburg, Pennsylvania 17325|
|Cherry Tree Cancer Center||Hanover, Pennsylvania 17331|
|The Kirklin Clinic at Acton Road||Birmingham, Alabama 35243|
|Barnes West County Hospital||Saint Louis, Missouri 63141|
|Christiana Care Health System-Christiana Hospital||Newark, Delaware 19718|
|Arizona Oncology-Deer Valley Center||Phoenix, Arizona 85027|