Gastric Cancer
Conditions
Interventions
Product Name: Cisplatin
Product Code: Cis
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Cisplatin
CAS Number: 15663-27-1
Concentration unit: mg/m2 milligram(s)/square meter
Concentrat
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 and 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the use of Hyperthermic Intraperitoneal Chemotherapy improves the overall survival or disease free interval in patients with advanced but resectable gastric cancer.;Secondary Objective: 1. Evaluation of treatment related toxicity (chemotherapy). 2. Comparison of the quality of life of patients undergoing either surgery or surgery and Hyperthermic Intraperitoneal Chemotherapy.;Primary end point(s): 2-5 year overall survival. | — |
Countries
United Kingdom
Outcome results
None listed