A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 222
- 主要终点
- Incidence of Chronic Neurotoxicity
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy.
PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).
详细描述
OBJECTIVES:
- Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.
- Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.
- Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.
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
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
- •Limited stage (I-IIIB)
- •Confined to 1 hemithorax
- •No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
- •Complete response after induction chemotherapy (with or without thoracic radiotherapy)
- •Consolidative chest radiotherapy may be initiated before study
- •No radiographic evidence of any of the following:
- •Brain metastases
- •Normal brain CT scan or MRI less than 1 month before study
- •Ipsilateral lung metastases
- •Malignant pleural effusion
- •Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 75,000/mm^3
- •Hemoglobin at least 10.0 g/dL^
- •Not specified
- •Not specified
- •See Disease Characteristics
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Neurological function class 1 or 2
- •No epilepsy requiring permanent oral medication
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other serious medical or psychiatric condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •At least 1 week since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
- •Concurrent thoracic radiotherapy allowed
- •Not specified
- •No concurrent antitumor agents
排除标准
- 未提供
研究组 & 干预措施
Arm I
Prophylactic cranial irradiation, 2.5 Gy fx
干预措施: Prophylactic cranial irradiation, 2.5 Gy fx (Radiation)
Arm II
Prophylactic cranial irradiation, 2.0 Gy fx
干预措施: Prophylactic cranial irradiation, 2.0 Gy fx (Radiation)
Arm III
Prophylactic cranial irradiation, 1.5 Gy fx
干预措施: Prophylactic cranial irradiation, 1.5 Gy fx (Radiation)
结局指标
主要结局
Incidence of Chronic Neurotoxicity
时间窗: From study registration to one year.
Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.
次要结局
未报告次要终点