Clinical Trials Directory

Trials / Completed

CompletedNCT01417507

Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery

Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma

Status
Completed
Phase
—
Study type
Observational
Enrollment
82 (actual)
Sponsor
Radiation Therapy Oncology Group · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.

Detailed description

PRIMARY OBJECTIVES: 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

Interventions

TypeNameDescription
PROCEDUREcognitive assessmentUndergo neurocognitive assessment
PROCEDUREmagnetic resonance imagingUndergo MRI
OTHERlaboratory biomarker analysisCorrelative studies
OTHERquestionnaire administrationAncillary studies
PROCEDUREquality-of-life assessmentAncillary studies

Timeline

Start date
2011-10-01
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2011-08-16
Last updated
2015-03-18

Locations

41 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT01417507. Inclusion in this directory is not an endorsement.