NCT00254436终止3 期
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Patients with Reduction in Red Blood Cell Transfusions
研究概览
简要总结
To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed by surgery.
详细描述
Anemia and fatigue are common problems in gastric and rectal cancer subjects at the completion of chemoradiation therapy and surgery. Results of several studies in cancer subjects suggest that treatment with epoetin alfa may be effective in maintaining hemoglobin levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially improving quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 years of age or older
- •Must have a confirmed diagnosis of gastric or rectal cancer for whom the treatment plan is preoperative chemoradiation followed by surgery
- •Must have a baseline hemoglobin >/= 10 g/dl and < 15 g/dl
- •Must have adequate hematologic function
- •Must have life expectancy of more than 6 months
- •Karnofsky performance status of at least 50%
- •Must have adequate renal function
- •Patients with reproductive potential must use an adequate contraceptive method during treatment and three months after completing treatment
- •Patients must be able to read, understand, and complete the three Quality of Life questionnaires in English.
排除标准
- •Prior chemotherapy for patients with rectal cancer
- •Gastric cancer patients who have received more than 2 cycles of chemotherapy
- •Anemia due to factors other than cancer/chemotherapy
- •Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 6 months
- •Known hypersensitivity to mammalian-cell derived products or to human albumin
- •Pregnant or lactating women
- •Untreated Central Nervous System metastases
- •Any significant, uncontrolled disease/dysfunction of any of the major organs
- •Uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
- •New onset or poorly controlled seizures
- •History of active second malignancy
- •Major infection requiring hospitalization and antibiotics or surgery within 14 days of study entry
- •Blood transfusion within 1 month of study entry
- •Androgen therapy within 2 months of study entry
研究组 & 干预措施
Epoetin Alfa
Experimental
干预措施: Procrit (epoetin alfa) (Drug)
结局指标
主要结局
Number of Patients with Reduction in Red Blood Cell Transfusions
时间窗: 2 years
Patient Iron Levels
时间窗: Every 4 weeks
Iron stores drawn at baseline and every four weeks.
次要结局
未报告次要终点
研究者
研究点 (1)
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