EUCTR2016-003394-18-DK进行中（未招募）1 期
Treatment of peritoneal carcinomatosis with Pressurized IntraPeritoneal Aerosol Chemotherapy- PIPAC-2 trial
Michael Bau Mortensen0 个研究点目标入组 137 人开始时间: 2016年9月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 137
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
- •Histological or cytological verified gastrointestinal-, ovarian- or primary peritoneal malignancy (based on tissue from the primary tumor and/or its metastases).
- •Ovarian cancer patients must be platinum resistant and have completed at least one line of chemotherapy for platinum resistant disease.
- •Radiological, histological or cytological evidence of PC.
- •No indication for CRS and HIPEC (according to National Guidelines).
- •Performance status 0-1.
- •No more than a single extra-peritoneal metastasis.
- •Age > 18 years.
- •Written informed consent must be obtained according to the local Ethics Committee requirements.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •Symptomatic small bowel obstruction (i.e. total parenteral nutrition, nasogastric tube).
- •Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin,
- •epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
- •A history of allergic reaction to platinum containing compounds or doxorubicin.
- •Renal impairment, defined as GFR < 40 ml/min, (Cockcroft-Gault Equation).
- •Myocardial insufficiency, defined as NYHA class > 2.
- •Impaired liver function defined as bilirubin = 1.5 x UNL (upper normal limit).
- •Inadequate hematological function defined as ANC = 1.5 x 109/l and platelets = 100 x109/l.
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