Voorbehandeling met chemotherapie, verwarmde buikspoeling met chemotherapie na chirugische verwijdering van alle tumor bij patienten met buikvlies uizaaiingen van dikke darm of endeldarm kanker.
- Conditions
- peritoneal metastasis, colorectal cancer, surgery, cytoreduction,HIPECperitoneaal metastasen, chirurgie, neo-adjuvante chemotherapie, cytoreductie, HIPEC
- Registration Number
- NL-OMON22353
- Lead Sponsor
- niversity Medcal Center Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
1. Peritoneal carcinomatosis of colorectal origin diagnosed either at laparotomy or by malignant ascites on CT-scan. When ascites is diagnosed, cytologic confirmation of peritoneal carcinomatosis is sufficient. At laparotomy either histologic or cytologic confirmation of peritoneal carcinomatosis is sufficient;
2. Age of 18 years of older;
1. Previous chemotherapy except adjuvant chemotherapy with an interval between the end of adjuvant chemotherapy and the start of neo-adjuvant chemotherapy of at least 12 months;
2. History of other malignancy, exept basal cell carcinoma;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of neo-adjuvant chemotherapy with respect to the percentage of patients who are resectable after neo-adjuvant chemotherapy.
- Secondary Outcome Measures
Name Time Method 1. The response of peritoneal carcinomatosis to chemotherapy according to RECIST criteria and postoperative pathological examination;<br /><br>2. Safety of neo-adjuvant chemotherapy and CRS+HIPEC with respect to 30-day or in-hospital mortality;<br /><br>3. Quality of life as measured by the EORTC-QLQ C30 quality of life questionnaire;<br /><br>4. Morbidity of surgery according to the NCI-CTC v4.0;<br /><br>5. The effect of chemotherapy and CRS with HIPEC on intestinal barrier function as measured by IFAB levels;<br /><br>6. The percentage of patients able to complete full treatment.