NCT00104936终止3 期
Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
European Organisation for Research and Treatment of Cancer - EORTC8 个研究点 分布在 3 个国家目标入组 9 人开始时间: 2004年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not yet known whether radiation therapy or radiosurgery is more effective than observation alone in treating benign meningioma.
PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see how well they work compared to observation alone in treating patients with newly diagnosed, benign meningioma that has been partially removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival of patients with newly diagnosed, incompletely resected, benign intracranial grade I meningioma treated with adjuvant conventional fractionated radiotherapy or radiosurgery vs observation only.
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare the incidence of a second surgery in patients treated with these regimens.
- Compare the incidence of acute and long-term neurotoxicity in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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:
- •Histologically confirmed newly diagnosed benign intracranial meningioma
- •WHO grade I
- •Any location except orbital meningioma
- •Mitotic index < 4 (total counts per 10 high-power field) AND MIB-1 labeling index < 4%
- •The following histologies are not allowed (i.e., WHO grade II or III):
- •Clear cell
- •Papillary
- •Anaplastic
- •Must have undergone non-radical resection* within the past 7 months
- •Post-operative MRI (performed 4 months after surgery) demonstrating stages 3, 4, or 5 NOTE: *Biopsy only is considered non-radical resection and may be classified as stage 4 or 5 according to tumor volume
- •No brain invasion
- •No hemangiopericytoma
- •No fibrous dysplasia or intra-osseous meningioma
- •No multiple meningiomas or meningiomatosis
- •Not part of neurofibromatosis type II
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No serious congestive heart failure
- •HIV negative
- •No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •No other disease that would preclude 5-year follow up after study completion
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance or study follow up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to the meninges or brain that would preclude study treatment
- •See Disease Characteristics
- •No prior randomization to this study
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Quality of life
- Overall survival
- Incidence of a second surgery
- Acute neurotoxicity
- Long-term neurotoxicity
研究者
研究点 (8)
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