Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 41
- 主要终点
- NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
结局指标
主要结局
NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)
时间窗: 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.
次要结局
- 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)