NL-OMON53132
Recruiting
Phase 3
Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study - PERISCOPE II study
Antoni van Leeuwenhoek Ziekenhuis0 sites226 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 226
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Investigators
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