Prospective multicenter phase III clinical trial using cytoreductive surgery with hyperthermic intraoperative chemotherapy (HIPEC) after preoperative chemotherapy in patients with peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction - Gastripec I

Klinik für Chirurgie, Charité Campus Virchow-Klinikum0 个研究点目标入组 180 人开始时间: 2011年2月14日最近更新: 2021年10月8日

研究概览

暂无简介。

•1) patients with gastric cancer incl. adenocarcinoma of the esophagogastreal junction and peritoneal carcinomatosis without any distant metastases with exception of Krukenberger tumosr
•2) peritoneal staging via laparoscopy and assessment of peritoneal carcinomatosis index (PCI) with the possibility of reduction (80% of the tumour) in line with zytoreductive surgery
•3) age = 18 and = 75 years
•4) Karnofsky Index = 70%
•5) written informed consent
•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 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

•1.) distant metastases except peritoneal carcinomatosis and Krukenberg tumors
•2.) other malignoma except curatively treated cervix carcinoma and basal cell carcinoma of the skin
•3.) previous chemotherapy or radiotherapx for peritoneal carcinomatosis
•4.) Inflammation in need of treatment
•5.) NYHA > 2
•6.) Myocardial infarction
•7.) cardiac arrhythmia
•8.) high blood pressure, constant > 180/100
•9.) cardiac function EF < 55%
•10.) Limited heart function
•11.) Insufficient renal function
•12.) Insufficient liver function
•13.) vaccinations during the last 6 weeks
•14.) Active hepatitis B/C
•15.) Pregnancy / lactation
•16.) No effective contraception
•17.) Missing of capacity to contract
•18.) contraindication to the drugs which are used in the trial
•19.) Participation in another investigational drug trial
•20.) Persons institutionalised due to regulatory actions ore by court order.

发起方

Klinik für Chirurgie, Charité Campus Virchow-Klinikum