NCT00310232终止3 期
Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)
Ontario Clinical Oncology Group (OCOG)30 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2001年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 30
- 主要终点
- Change in anemia and fatigue related QoL at 12 weeks following randomization
研究概览
简要总结
The general objective of this study is to improve the Quality of Life (QoL) of selected patients with advanced carcinoma of the lung. The specific objective is to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related QoL and anemia in non-small cell lung cancer patients with advanced stage disease and underlying anemia of malignancy.
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
- Double
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
- •Histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage III or IV, or recurrent disease; and
- •Hemoglobin level at or below 120 g/L; and
- •At least 18 years of age;
排除标准
- •Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
- •Patients previously treated with high dose thoracic radiation (>10 fractions), or surgery, without objective evidence of disease recurrence;
- •Planned high dose thoracic radiation therapy (>10 fractions);
- •A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;
- •Expected survival of three months or less;
- •ECOG Performance status of 3 or 4 (see Appendix D);
- •Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required);
- •Blood transfusions within the last 14 days;
- •Previous use of erythropoietin;
- •Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
- •Evidence of untreated folate or vitamin B12 deficiency;
- •History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;
- •History of seizure disorder;
- •Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
- •Pregnancy, lactation or parturition within the previous 30 days;
- •Unwillingness or inability to complete the required QoL questionnaires;
- •Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
- •Geographically inaccessible for treatment or follow-up evaluations;
- •Currently enrolled in an ongoing therapeutic study;
结局指标
主要结局
Change in anemia and fatigue related QoL at 12 weeks following randomization
时间窗: 12 weeks following randomization
次要结局
- hemoglobin and hematocrit levels(6 months from randomization)
- Overall QoL and domain-specific QoL scores(16 weeks following randomization)
- number of transfusions(6 months from randomization)
研究者
研究点 (30)
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