NCT00238264已完成2 期
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 145
- 主要终点
- Marginal-failure Rate
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.
详细描述
OBJECTIVES:
Primary
- Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.
Secondary
- Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen.
- Determine quality of life of patients treated with this regimen.
- Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients.
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
- 3 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed* low-grade glioma, including any of the following:
- •Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA
- •Diffuse astrocytoma, including any of the following subtypes:
- •Fibrillary astrocytoma
- •Gemistocytic astrocytoma
- •Subependymal giant cell astrocytoma
- •Pleomorphic xanthoastrocytoma
- •Low-grade oligoastrocytoma
- •Low-grade oligodendroglioma
- •Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions who have contiguous extension of tumor into other regions of the visual pathway by CT scan or MRI are eligible without histopathologic confirmation; repeat biopsy required for patients with recurrent tumors that enhance but whose initial tumor did not
- •Measurable disease by radiography
- •Meets any of the following criteria:
- •Progressive nonresectable disease
- •Any location in the brain
- •Patients with a less than gross total resection are eligible provided they are symptomatic from their tumor OR the risk from neurologic impairment with progression is high enough to warrant immediate treatment
- •Has undergone biopsy only
- •Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)
- •Prior chemotherapy optional (for patients ≥ 10 years of age)
- •No type-1 neurofibromatosis
- •No evidence of leptomeningeal dissemination
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 50-100% (for patients > 16 years of age) OR
- •Lansky 50-100% (for patients ≤ 16 years of age)
- •Life expectancy
- •At least 1 year
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3 (transfusion independent)
- •Hemoglobin ≥ 10.0 g/dL (transfusions allowed)
- •Not specified
- •Not specified
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Not in status epilepticus, coma, or requiring assisted ventilation prior to study entry
- •Patients with a seizure disorder are eligible provided they are on anticonvulsants AND disease is well controlled
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •Concurrent dexamethasone allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry
- •Concurrent dexamethasone allowed for symptoms of increased intracranial pressure
- •Radiotherapy
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (radiotherapy)
Experimental
Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Marginal-failure Rate
时间窗: Up to 5 years
Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.
次要结局
- Quality of Life (QOL)(Up to 5 years)
- Correlation MIB-1 Labeling Index With PFS(Up to 10 years)
- Overall Survival Probability(3 years)
- Progression-free Survival Probability(3 years)
- Event-free Survival Probability(3 years)
- MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods(At baseline)
研究者
研究点 (145)
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