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Voorbehandeling met chemotherapie, verwarmde buikspoeling met chemotherapie na chirugische verwijdering van alle tumor bij patienten met buikvlies uizaaiingen van dikke darm of endeldarm kanker.

Recruiting
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
Inclusion Criteria

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;

Exclusion Criteria

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
NameTimeMethod
Efficacy of neo-adjuvant chemotherapy with respect to the percentage of patients who are resectable after neo-adjuvant chemotherapy.
Secondary Outcome Measures
NameTimeMethod
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.
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