EUCTR2012-004103-12-FR进行中（未招募）不适用
ISOTOVE studyIsotopic study of the intraperitoneal distribution of locoregional post surgery chemotherapy for peritoneal carcinomatosis of ovarian origin
Centre Jean Perrin0 个研究点开始时间: 2013年6月11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
- Female
入选标准
- •- Age> 18 years.
- •-Performance status 0-2
- •- ANC> 1.5.109 / L (without the addition of GCSF)
- •-Platelets> 100. 109 / L
- •-Bilirubin -AST and ALT Alkaline-Phosphatase - Creatinine -PTT <1.5 times the upper normal value (heparin, or other anticoagulants lovenox accepted)
- •-PT/INR - Patient operated first line without macroscopic residue for ovarian cancer or primary peritoneal or tubal stage IIIC peritoneal or pleural IV
- •-Minimum required for surgery: hysterectomy, bilateral salpingo-oophorectomy, omentectomy and pelvic lymphadenectomy para-aortic
- •- Patient requiring adjuvant chemotherapy
- •- Compulsory affiliation to a social security scheme.
- •- Obtaining informed consent in writing, signed and dated.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Patient aged 70 years and over
- •- Patient with cognitive or psychiatric conditions.
- •- Patient deprived of liberty by a court or administrative order.
- •- Patient with indications against the realization of chemotherapy
- •- Concomitant treatment with a drug test, participation in another therapeutic clinical trial < 30 days
- •- Pregnant Women
- •- Breastfeeding
- •Sensory neuropathy, motor or > grade 1 (CTCAE)
- •-Hepatitis or severe infection requiring parenteral antibiotics
- •- Serious non-healing wound or ulcer, or bone fracture
- •-Abdominal fistula or gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to intraperitoneal chemotherapy
- •-Clinical symptoms or signs of gastrointestinal obstruction and / or require hydration and / or parenteral nutrition
- •-Patients who have had or are currently having an inflammatory disease of the bowel
- •- Active bleeding or pathological condition that carries a high risk of bleeding (eg, bleeding disorders known coagulopathy, or tumor with large vessels)
- •- Stroke (CVA) or transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
- •- Cardiovascular disease clinically significant, including:
- •o Uncontrolled hypertension, defined as systolic blood pressure> 150 mm Hg or diastolic> 90 mm Hg
- •o myocardial infarction or unstable angina within the past 6 months
- •o NYHA class II-IV congestive heart failure
- •o serious cardiac arrhythmia requiring treatment:
- •-Asymptomatic atrial fibrillation with controlled ventricular or supraventricular tachycardia controlled with medication and is authorized asymptomatic
- •o Peripheral vascular disease = grade 2 (CTCAE) (short [less than 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
- •-History hemorrhage or cerebral vascular accident (CVA), transient ischemic attack, or subarachnoid in the last 6 months
- •-Major surgery within 28 days before enrollment
研究者
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