Study for prevention of peritoneal carcinomatosis in patients with stomach cancer - HIPEC_Stomach

niversity Hospital Tübingen0 个研究点开始时间: 2012年1月6日最近更新: 2015年8月4日

试验速览

暂无简介。

•1.histologically confirmed Adenocarcinoma of the stomach: uT2, uT3, all N, M0
•2.no previous cytostatic chemotherapy
•3.Both genders (female and male patients)
•4.Age > 18. Patients to be at an age where reproduction is possible have to practice reliable methods of contraceptions („Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals [CPMP/ICH/286/95 mod]) during the study until 3 month after study participating. Female subjects will only be included if they have negative pregnancy test during screening.
•5.ECOG = 2
•6.No distant metastasis after CT in lung and abdomen, in clinical suspicion exclusion of bone metastasis with bone scintigraphy or MRI
•7.Leucozytes > 3.000/µl
•8.Thrombozytes > 100.000/µl
•9.Serum creatinine = 1.5x of standard value, or Creatinine-Clearance > 60 ml/min
•10.Written informed consent obtained prior to study entry
•11.Normal ejektion fraction in echocardiography prior to therapy
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Distant metastasis, and any non-resectable stadium
•2.Hypersensitivity, contraindications for 5-FU, Leucovorin, Oxaliplatin, Cisplatin, Epirubicin oder Docetaxel (see SmPC)
•3.Active Coronary Heart Disease, Cardiomyopathy or Heart failure (NYHA stadium III-IV)
•4.malignant secondary disease < 5 years ago (exception: cervical In-situ-Carcinoma, adequate treated Basal cell carcinoma
•5.any major internal secundary disease or acute infections
•6.Polyneuropathy > NCI Grade II
•7.severe hepatic disfunction (AST/ALT > 3,5xULN, AP > 6xULN, Bilirubin > 1,5xULN)
•8.Inflammatory bowel disease
•9.Participation in another clinical study
•10.Pregnancy or lactation period

发起方

niversity Hospital Tübingen