EUCTR2012-005329-56-DK进行中（未招募）不适用
A phase ll trial of combination chemotherapy with intravenous oxaliplatin combined with tablet capecitabin in patients with recidivant breastcancer - capox
Dept of oncology0 个研究点目标入组 50 人开始时间: 2013年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Informed concent Age > 18 years
- •Performance status 0-1; expected survival > 3 months
- •Prior treatment with a Taxane and antracyclin
- •No treatment with capecitabine and oxaliplatin
- •Evaluable disease (recist 1.1)
- •neu granulocytes > 1,5, thrombocytes >100
- •bilirubine <2 x UNL
- •Creatinine-clearence >30 ml/min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •History of chemotherapy within the 4-week period prior to the start of
- •trial medication
- •Other current or prior malignant disease except adequately treated
- •and cured carcinoma in situ of the cervix or squamous cell carcinoma of
- •Previous treatment with oxaliplatin
- •Cytotoxic or experimental treatment within a 14 days period before
- •start of trial medication
- •Current participation in other clinical trials
- •Any clinical symptoms suggesting peripheral neuropathy grade 2 or
- •CNS metastases (In case of clinical suspicion on CNS metastases a MR or
- •CT scan must be conducted within 4 weeks before inclusion)
- •Other severe medical conditions e.g. severe cardiovascular disease or
- •AMI < 1 year
- •Medical diseases or condition affecting the patients compliance with
- •peroral study drug
- •Patients with uncontrolled infection
- •Pregnant or lactating women
- •Women capable of childbearing not using a sufficient non-hormonal
- •method of birth control (spiral)
- •Patients who due to physiological, intelectual, cultural reasons, or
- •lack of language capabilities, an unable to comply with the treatment
- •concept or to place the patient at high risk from treatment related
- •complications
- •Prior serious or unsuspected reaction to fluorpyrimidin therapy
- •Known prior hypersensitivity reactions any components used
研究者
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