Randomized Phase II Trial of Conventional vs IMRT Whole Brain Radiotherapy for Brain Metastases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Alopecia
研究概览
简要总结
In this study the patient will receive either whole brain radiation therapy given by intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT therapy radiation dose to the parts of the brain that do not contain tumors is reduced. This study will look to see if this approach results in less hair loss or fewer memory Problems, as compared to the standard technique. The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.
详细描述
SCHEMA For Patients with MRI Evidence of Brain Metastasis within 1 Month Prior to Registration
Prior to Treatment Start Confirmation of patient's insurance coverage prior to receiving study-related procedures to e ensure that treatment with IMRT will not be denied.
Radiation Therapy
- MRI with Fused CT Simulation
- Neurocognitive Function Testing
- Quality of Life Assessment
Arm 1 Whole brain radiation therapy delivered via IMRT (37.5 Gy to the brain tumors, 30 Gy to the uninvolved brain in 15 fractions), mean dose of less than 18 Gy to the scalp
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •ELIGIBILITY CHECKLIST
- •Inclusion Criteria:
- •Evidence of at least one brain metastasis on a gadolinium contrast-enhanced MRI
- •Pathologic/histological/cytologic proof of a diagnosis of a non-hematopoietic malignancy within 5 years of study entry.
- •Patient ≥18 years of age?
- •Fall into RTOG Recursive Partition Analysis (RPA) class I or II.
- •Karnofsky Performance Score ≥
- •(See Appendix III)
- •Biopsy done at least 1 week prior to registration. (This requirement does not apply to stereotactic biopsies.)
排除标准
- •Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia.
- •Creatinine level > 1.4 mg/dl drawn ≤30 days prior to study entry.
- •Severe, active co-morbitities.
- •Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •Uncontrolled, clinically significant cardiac arrhythmias
- •Pregnancy
结局指标
主要结局
Alopecia
时间窗: 1 to 4 months after radiation
In this study the patient will receive either whole brain radiation therapy given by intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT therapy radiation dose to the parts of the brain that do not contain tumors is reduced.
次要结局
- The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.(1 year)
- Quality of life(1 year after radiation)
研究者
Johnny Kao
Principal Investigator
Good Samaritan Hospital Medical Center, New York