Hyperthermic Intraperitoneal Chemotherapy - Gastric Cancer - HIPC in gastric cancer

niversity of Dundee0 sites62 target enrollmentSeptember 22, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 22, 2005

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Dundee

•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.

•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