Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 64
- 主要终点
- Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months
研究概览
简要总结
RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.
PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy.
Secondary
- Compare time to CNS (brain) failure in patients treated with these regimens.
- Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens.
- Compare post-treatment toxicity in these patients.
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cerebral metastases meeting the following criteria:
- •One to three presumed brain metastases
- •Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate)
- •Histologic confirmation may have been from the primary tumor site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s)
- •Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days
- •Lesions must not be within 5 mm of the optic chiasm or within the brainstem
- •Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery confirmed by a radiation oncologist
- •No primary germ cell tumor, small cell carcinoma, or lymphoma
- •No leptomeningeal metastases
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Menopausal status not specified
- •ECOG performance status 0-2
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Male patients must continue to use contraception for 3 months after the completion of radiotherapy
- •No pacemaker or other MRI-incompatible metal in the body
- •No known allergy to gadolinium
- •PRIOR CONCURRENT THERAPY:
- •More than 7 days since prior and no concurrent chemotherapy
- •No prior cranial radiotherapy
- •No prior resection of cerebral metastases
- •Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo stereotactic radiosurgery (SRS)
干预措施: stereotactic radiosurgery (Radiation)
Arm II
Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
干预措施: stereotactic radiosurgery (Radiation)
Arm II
Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months
时间窗: 3 months post radiosurgery
The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.
次要结局
- Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months(From baseline to 12 months)
- Overall Survival(Up to 5 years)
- Number of Participants With Local and Distant Tumor Control up to 3 Months(Up to 3 months)
- Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month](From Baseline to 3-Month Evaluation)