Hyperthermic Intraperitoneal Chemotherapy - Gastric Cancer - HIPC in gastric cancer

niversity of Dundee0 个研究点目标入组 62 人开始时间: 2005年9月22日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1.Age > 18 and < 80 year of age
•2.Pre-operative histologically proven adenocarcinoma of the stomach, including Type III junctional tumours, diagnosed at endoscopy 49.
•3.AJCC stage II / IIIA / IIIB (T3 N0-2 Mo) (see table 1) assessed by spiral or multi-slice CT with confirmatory evidence of serosal penetration on EUS)
•4.Completed radical subtotal / total gastrectomy with D2 regional lymphadenectomy
•5.No previous chemotherapy, radiotherapy or other investigational drug treatment for gastric cancer in a previous episode
•6.WHO performance status 0,1 or 2
•7.No concurrent uncontrolled medical condition
•8.Adequate bone marrow function with WBC > 3 x 109/l, neutrophils > 1.5 x 109/l and platelets > 100 x 109/l at the time of study entry
•9.Serum creatinine < 180 µmol/l and measured creatinine clearance over 60ml/min
•10.Serum bilirubin < 35 µmol/l.
•11.No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the previous 10 years
•12.Adequate contraceptive precautions (if relevant)
•13.Informed written 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•a.Presence of locally metastatic disease (including macroscopic peritoneal disease) preventing curative resection (AJCC stage IV or M1)
•b.Medical or psychiatric conditions which compromise the patient’s ability to give informed consent
•c.Uncontrolled angina or severe metabolic disease (poorly controlled diabetes)
•d.Impaired renal function (measured creatinine clearance < 60ml/min)
•e.Active liver disease (cirrhosis or hepatitis)
•f.Significant hearing loss

发起方

niversity of Dundee