EUCTR2013-000138-37-NL进行中（未招募）不适用
Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy - PERISCOPE-study
KI-Av0 个研究点开始时间: 2013年7月1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
- •Biopsy proven adenocarcinoma of the stomach (including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach for which the intended surgical treatment is a gastric resection and not a resection of the oesophagus and cardia)
- •T3-T4 tumour based upon CT-scan and/or EUS results
- •Tumour positive peritoneal cytology and/or peritoneal carcinomatosis limited to the upper abdominal cavity (above the transverse colon) and/or at the most at one location in the lower abdominal cavity (e.g., Douglas’ pouch, ovarian metastasis, Sister Mary Joseph nodule) confirmed by diagnostic laparoscopy
- •Age = 18 years
- •WHO performance status 0-1
- •ASA classification I-III
- •Adequate bone marrow, hepatic and renal function, i.e., minimal acceptable laboratory values at start of the study inclusion:
- •a. ANC = 1.5 x 10^9 /L
- •b. Platelet count = 100 x 10^9 /L
- •c. Serum bilirubin = 1.5 x ULN, and ALAT and ASAT = 2.5 x ULN
- •d. Creatinine clearance = 50 ml/min (measured or calculated by Cockcroft-Gault formula).
- •Wildtype for DPD*2A
- •Negative pregnancy test (urine/serum) for female patients of childbearing potential
- •Life expectancy = 3 months allowing adequate follow up
- •Able and willing to undergo blood sampling for pharmacokinetics
- •Written informed consent
- •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) no
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination
- •Signs of local irresectability
- •Recurrent gastric cancer
- •Metachronous peritoneal carcinomatosis
- •Prior treatment of gastric cancer with systemic anticancer therapy
- •Pregnancy, breast feeding or active pregnancy ambition
- •Unreliable contraceptive methods. Patients enrolled in this trial must agree to use a reliable contraceptive method throughout the study
- •Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type
- •A known history of hepatitis B or C with active viral replication
- •Recent myocardial infarction (< 6 months) or unstable angina.
- •Uncontrolled diabetes mellitus
- •Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment
- •Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
研究者
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