EUCTR2008-000217-30-IT进行中（未招募）不适用
Treatment with Oxaliplatin and Irinotecan in colorectal metastatic tumors with high expression of thymidilate synthase (TS). - IRINOX
AZIENDA OSPEDALIERA SENESE0 个研究点开始时间: 2008年2月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- All
入选标准
- •Patients with metastatic colorectal adenocarcinoma that has not received a previous chemotherapy for metastatic disease.
- •Availability of tumor tissue from metastatic sites for immunoistochemical determination of Thymidilate synthase (TS).
- •Patients who had received adjuvant chemotherapy may be enrolled if they were disease free tratment for at least 6 months after the stop of adjuvant therapy.
- •ECOG Performance status of 0-2.
- •Measurable or evaluable metastatic disease.
- •Life expectancy of at least 3 months.
- •Adequate haematologic parameters (neutrophils 1.5 x 109 /L, and platelets 100x 109 /L), serum creatinine and total bilirubin 1.25 times the upper limit of normal range; transaminases < 3 times the upper limit pf normal range.
- •Absence of a second tumor with the exception of non-melanoma tumor or in situ carcinoma of the cervix.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Metastatic disease pretreated with chemotherapy
- •Resectable metastatic disease
- •Not availability of metastatic tumor tissue
- •Congestive heart failure
- •Cronic diarrhea
研究者
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