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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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 or laparotomy
• Treated with three courses of neoadjuvant chemotherapy consisting of a curative or palliative regimen, with the last course ending within 6 weeks prior to inclusion
• 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).
• 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

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 resection of the primary gastric tumour
• 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment related toxicity (graded according to the NCI Common Toxicity<br /><br>Criteria version 4.0)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- postoperative morbidity and mortality<br /><br>- pharmacokinetic parameters (systemic, intraperitoneal fluid concentrations of<br /><br>oxaliplatin and docetaxel)<br /><br>- cytoreductive completeness score<br /><br>- patterns of tumour recurrence<br /><br>- disease free and overall survival</p><br>

Related Trials