Hyperthermic Intraperitoneal Chemotherapy - Gastric Cancer - HIPC in gastric cancer

Phase 1

• Conditions: Gastric Cancer

• Registration Number: EUCTR2005-004280-31-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-22
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>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.