NL-OMON34109已完成不适用
eutrophil-guided dosing of anthracycline/cyclophosphamide chemotherapy in patients with breast cancer: a feasibility study - ANC-guided dosing of cHemOtheRapy: The ANCHOR-study.
Ikazia Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •(1) breast cancer patients aged >=18 years planned for treatment with at least three cycles of one of the above-mentioned ACC-regimens (AC, FAC, or FEC) at the Department of Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands
- •(2) WHO performance status 0-1
- •(3) Life expectancy >3 months
- •(4) Adequate peripheral blood counts: leukocytes >=4.0x109/L and ANC >=2.0x109/L and platelet count >=150x109/L
- •(5) Adequate renal function defined as normal serum creatinine concentration and/or estimated creatinine clearance >=60 mL/min (by Cockroft-Gault formula: [140 - age (years)] x 1.05 x body weight (kg)] : serum creatinine concentration (µmol/L))
- •(6) Adequate liver function defined as normal serum bilirubin concentration (<=17 µmol/L) and serum ASAT and ALAT <=3 times the upper limit of normal (<=5 times the upper limit of normal in case of hepatic metastases)
- •(7) Normal serum albumin concentration (35-50 g/L)
- •(8) Written informed consent
排除标准
- •(1) Previous treatment with chemotherapy
- •(2) Unable to consent with weekly follow-up for blood counts and toxicity assessment
- •(3) Symptomatic brain metastasis
- •(4) History of cardiac dysfunction
- •(5) Uncontrolled arterial hypertension (blood pressure systolic >=180 mmHg and/or diastolic >=110 mmHg) and/or unstable angina pectoris
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