Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Adult Diffuse Astrocytoma
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 82
- Locations
- 41
- Primary Endpoint
- NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Central pathology confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma prior to step 2 registration
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)
Time Frame: Up to 5 years
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.
Secondary Outcomes
- Frequency of seizures, evaluated using patient seizure diary(Up to 5 years)
- Symptomatic or clinical progression(Up to 5 years)
- Molecular correlates of QOL, NCF, seizure control, and PFS(Up to 5 years)
- Time to neurocognitive decline in patients who progress and who do not progress radiologically, as defined by the RCI-WSD(Up to 5 years)
- PFS(The interval from registration to progression or death, whichever occurs first, assessed up to 5 years)
- Effect of salvage therapy on cognitive outcomes in patients who progress(Up to 5 years)
- QOL as measured by the EORTC QOL-30, EORTC QOL-BCN20, and EQ-5D(Up to 5 years)
- Radiological progression(Up to 5 years)
- OS(Up to 5 years)