Treatment of peritoneal metastases in stomach cancer patients with extensive surgery and heated intraperitoneal chemotherapy
- Conditions
- Gastric cancer with limited peritoneal dissemination, i.e., positive peritoneal cytology or peritoneal dissemination limited to the upper abdomen with at most one location in the lower abdomen.
- Registration Number
- NL-OMON21196
- Lead Sponsor
- The Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam, The NetherlandsSt. Antonius Hospital, Nieuwegein, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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
Exclusion Criteria
• Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination
• Signs of local irresectability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment related toxicity (graded according to the NCI Common Toxicity Criteria version 4.0)
- Secondary Outcome Measures
Name Time Method - postoperative morbidity and mortality<br /><br>- completion of the study protocol<br /><br>- pharmacokinetic parameters<br /><br>- cytoreductive completeness score<br /><br>- peritoneal cancer index<br /><br>- patterns of tumour recurrence<br /><br>- disease free and overall survival<br />