Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study
- Conditions
- Adenocarcinoma of the stomachgastric cancer100179901001799110017998
- Registration Number
- NL-OMON53132
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 226
- Age >= 18 years
- cT3-cT4 adenocarcinoma (or undifferentiated carcinoma) of the stomach,
considered to be resectable
- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal
cytology (proven by laparoscopy or laparotomy)
- Absence of disease progression during systemic treatment (prior to inclusion)
- WHO performance status 0-2
- Adequate bone marrow, hepatic and renal function
- Distant metastases or small bowel dissemination
- Recurrent gastric cancer
- Prior resection of the primary gastric tumour
- Non-synchronous peritoneal carcinomatosis
- Current other malignancy (other than cervix carcinoma and basalioma)
- Hepatitis B or C, known HIV infection or an uncontrolled infectious disease
- Recent myocardial infarction (< 6 months) or unstable angina
- Uncontrolled diabetes mellitus
- Pregnancy or breast feeding
- Any medical condition that is considered to interfere with study procedures
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>The study endpoint is overall survival. The hypothesis is that the median<br /><br>overall survival of the patients treated according to protocol in the<br /><br>experimental arm is 12 months, as compared to a median overall survival of 4<br /><br>months in the standard arm.</p><br>
- Secondary Outcome Measures
Name Time Method