NCT01227954已完成2 期
A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 63
- 主要终点
- Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
研究概览
简要总结
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.
详细描述
OBJECTIVES:
Primary
- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) at 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) in patients with brain metastasis.
Secondary
- Evaluate auditory and visual learning and memory, as assessed by two CogState tests (International Shopping List Test and One Card Learning Test), after HA-WBRT in these patients.
- Compare psychometric properties of the 2 CogState tests to the HVLT-R for the assessment of memory decline after HA-WBRT in these patients.
- Evaluate health-related quality of life [as assessed by the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR) and the Barthel Index of Activities of Daily Living (ADLs)] after HA-WBRT in these patients.
- Evaluate time to radiographic progression after HA-WBRT in these patients.
- Evaluate overall survival of these patients after HA-WBR.
- Evaluate the adverse events of HA-WBR.
- Evaluate predictive biomarkers of cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed non-hematopoietic malignancy within the past 5 years
- •If histologic proof of malignancy is from > 5 years ago, then a more recent pathological confirmation is required (e.g., from systemic metastatic or brain metastasis)
- •Patients with metastasis of unknown primary tumor are permitted
- •Measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast-enhanced MRI obtained within the past 30 days
- •Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection
- •These treatment options are allowed only at relapse
- •Patients who have brain metastases at initial presentation allowed and do not need to demonstrate 3 months of stable scans
- •At least 1 week since open biopsy
- •Karnofsky performance status 70-100%
- •Fertile patients must use effective contraception
- •Negative pregnancy test 2 weeks or less prior to study entry
- •Patients must be English proficient, with patients who speak English as a second language eligible
排除标准
- •Small cell lung cancer or germ cell malignancy
- •Leptomeningeal metastases
- •Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of extracranial metastases
- •Radiologic evidence of hydrocephalus
- •Serum creatinine > 1.4 mg/dL within 30 days prior to study entry
- •Pregnant or nursing
- •Contraindication to MRI imaging such as implanted metal devices or foreign bodies or severe claustrophobia
- •Severe, active co-morbidity including any of the following:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- •Transmural myocardial infarction within the past 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- •Uncontrolled, clinically significant cardiac arrhythmias
- •Prior radiotherapy to the brain
- •Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7 days
研究组 & 干预措施
WBRT with Hippocampal Avoidance
Other
Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
时间窗: Baseline and 4 months from start of treatment
Change in Hopkins Verbal Learning Test-Revised delayed recall (HVLT_R DR) score from baseline to 4 months after the start of treatment calculated as (baseline score - 4 month score)/ baseline score. A positive change indicates a decline in function. The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms, helping to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. Delayed recall involves recalling a list of 12 targets after a 20-minute delay. The score is the sum of the number of targets correctly recalled. Percent change calculated as 100\*\[(baseline score - 4 month score)/ baseline score\]
次要结局
- Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)(Baseline and 4 months from start of treatment)
- ApoE4 Genotype and Other Potentially Predictive Biomarkers of Cognitive Function(Baseline and 4 months from start of treatment)
- Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT)(Baseline and 4 months from start of treatment)
- Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT)(Baseline and 4 months from start of treatment)
- Progression-free Survival(Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.))
- Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL)(Baseline and 4 months from start of treatment)
- Overall Survival(Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.))
- The Frequency of Patients With Grade 3 and Higher Adverse Events (AE) Related to Treatment(From start of treatment to 12 months from start of treatment)
研究者
研究点 (63)
Loading locations...
相似试验
招募中
2 期
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung CancerMetastatic Malignant Neoplasm in the LeptomeningesMetastatic Breast CarcinomaStage IV Lung Cancer AJCC v8Metastatic Lung Non-Small Cell CarcinomaAnatomic Stage IV Breast Cancer AJCC v8NCT06518057University of Washington22
已完成
2 期
Phase 2 Trial in Multiple Brain Metastases Outcomes With HA-SIB-WBRTBrain MetastasesNCT04452084National Cancer Centre, Singapore42
已完成
2 期
Spinal Cord Compression Re-Treat StudyRadiation ToxicitySpinal Cord CompressionPainUnspecified Adult Solid Tumor, Protocol SpecificNCT00974168Cancer Trials Ireland22
已完成
2 期
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or SarcomaKidney CancerMetastatic CancerMelanoma (Skin)Ovarian CancerSarcomaNCT00003308Eastern Cooperative Oncology Group
已完成
不适用
Radiation Therapy During Surgery in Treating Older Women With Stage I Breast CancerBreast CancerNCT00556777Institut du Cancer de Montpellier - Val d'Aurelle42