Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy

• Conditions: Gastric cancer with peritoneal carcinomatosis or positive peritoneal cytology.; MedDRA version: 16.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 100000004856; MedDRA version: 16.0Level: PTClassification code 10067093Term: Intraperitoneal hyperthermic chemotherapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000138-37-NL
• Lead Sponsor: KI-Av

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-01
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Biopsy proven adenocarcinoma of the stomach (including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach for which the intended surgical treatment is a gastric resection and not a resection of the oesophagus and cardia)
• T3-T4 tumour based upon CT-scan and/or EUS results
• Tumour positive peritoneal cytology and/or peritoneal carcinomatosis limited to the upper abdominal cavity (above the transverse colon) and/or at the most at one location in the lower abdominal cavity (e.g., Douglas’ pouch, ovarian metastasis, Sister Mary Joseph nodule) confirmed by diagnostic laparoscopy
• Age = 18 years
• WHO performance status 0-1
• ASA classification I-III
• Adequate bone marrow, hepatic and renal function, i.e., minimal acceptable laboratory values at start of the study inclusion:
a. ANC = 1.5 x 10^9 /L
b. Platelet count = 100 x 10^9 /L
c. Serum bilirubin = 1.5 x ULN, and ALAT and ASAT = 2.5 x ULN
d. Creatinine clearance = 50 ml/min (measured or calculated by Cockcroft-Gault formula).
• Wildtype for DPD*2A
• Negative pregnancy test (urine/serum) for female patients of childbearing potential
• Life expectancy = 3 months allowing adequate follow up
• Able and willing to undergo blood sampling for pharmacokinetics
• Written informed 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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

• Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination
• Signs of local irresectability
• Recurrent gastric cancer
• Metachronous peritoneal carcinomatosis
• Prior treatment of gastric cancer with systemic anticancer therapy
• Pregnancy, breast feeding or active pregnancy ambition
• Unreliable contraceptive methods. Patients enrolled in this trial must agree to use a reliable contraceptive method throughout the study
• Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type
• A known history of hepatitis B or C with active viral replication
• Recent myocardial infarction (< 6 months) or unstable angina.
• Uncontrolled diabetes mellitus
• Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment
• Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents

Study & Design

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