A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 36
- 主要终点
- Compare the effects of these regimens on increasing hemoglobin levels
研究概览
简要总结
RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
详细描述
OBJECTIVES:
- Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.
- Compare the effects of these regimens on increasing hemoglobin levels in these patients.
- Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).
All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Compare the effects of these regimens on increasing hemoglobin levels
时间窗: Up to 1 year post-treatment
次要结局
- Compare the effects of anemia-specific components of QOL(Up to 1 year post-treatment)
- Compare the effects of these regimens on overall quality of life (QOL)(Up to 1 year post-treatment)