EUCTR2016-003294-18-IT进行中（未招募）1 期
Phase II Study of Neoadjuvant Chemotherapy With Dose-Dense Paclitaxel In Association With Carboplatin followed by Radical Surgery for Locally Advanced Cervical Cancer (FIGO stage IB2- IIIA) Patients. - DOSE DENSE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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
- •Histologic diagnosis of squamous cervical cancer or adenocarcinoma
- •Clinical diagnosis of FIGO stage IB2-IIIA at gynecological examination
- •ECOG Performance Status (ECOG PS): 0-1
- •Age > 18 and < 75 years
- •Life expectancy of at least 3 months
- •Written informed consent
- •Ability and willingness to comply with treatment and follow up assessments and procedures
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- •Serious heart disease, including heart failure, atrioventricular block of any degree, serious arrhythmia or history of one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
- •Hemoglobin < 9 g/dL, neutrophils < 1500/mm3, platelets < 100000/mm3
- •Impairment of renal function: creatinine > 1.5 times the upper normal limit – UNL; calculated creatinine clearance < 50 mL/min; urine protein to creatinine ratio > 1: then, a 24-hour urine protein must be assessed and subject must have a 24-hour urine protein value <1gr to be eligible
- •Impairment of liver function (SGOT or SGPT > 2.5 UNL, alkaline phosphatase > 2.5 ULN, total bilirubin > 1.5 times the UNL)
- •Prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (PTT) > 1.2 times the UNL
- •Pregnancy or breast feeding patients
- •Any clinical conditions which can represent a contraindications to major surgery
- •Localizations of disease not amenable for radical surgery
- •Patients' inability to access the centre due to area of residence.
研究者
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