EUCTR2012-005282-12-GB进行中（未招募）不适用
TOFFEE TrialToxicity OF Fluoropyrimidines: A comparative study of the cardiotoxicity of capEcitabine and tEysuno - TOFFEE Trial
niversity of Edinburgh0 个研究点开始时间: 2013年6月3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
- •Male or female patients at least 18 years or over with no upper age limit.
- •Confirmed advanced or metastatic oesophageal, gastric, gastro-oesophageal, small bowel, colorectal, cancer of unknown primary, hepatobiliary or pancreatic cancer.
- •Suitable for treatment with fluoropyrimidine, either alone or in combination with oxaliplatin.
- •WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo planned chemotherapy and cardiac investigations.
- •Baseline laboratory tests (within 1 week prior to starting treatment):
- •-Neutrophils >1.5 x109 /L and platelet count > 100 x109 /L
- •-Serum bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase <5x ULN, and serum transaminase (either AST or ALT) <3 x ULN
- •-Estimated creatinine clearance (Cockcroft and Gault, adjusted for BSA>50 mL/min or estimated glomerular filtration rate (eGFR) or measured GFR (EDTA clearance) >30 mL/min. [Patients with Cr Cl 30-50 mL/min will be included but should be treated at a reduced dose (see master prescription chart)]
- •For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions.
- •Effective contraception for male patients if the risk of conception exists.
- •Written informed consent for participation in the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients who are unfit for the chemotherapy regimens in this protocol, such as:
- •-Severe uncontrolled concurrent medical illness (including poorly controlled angina or very recent MI, i.e. in previous 3 months) likely to interfere with protocol treatments
- •-Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
- •-Partial or complete bowel obstruction
- •-Pre-existing neuropathy > grade 1 if combination therapy proposed DELETED
- •Patients on therapeutic anticoagulation (warfarin or LMWH).
- •Patients unable to lie flat. DELETED
- •Patients unable to withstand the visits and cardiovascular investigations proposed within the study.
研究者
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