eo-adjuvant chemotherapy, cytoreductive surgery with hypethermic intraperitoneal chemotherapy for peritoneal carcinomatosis of colorectal origin.
Phase 2
Completed
- Conditions
- peritoneal cancerperitoneal carcinomatosis100346521001799110017998
- Registration Number
- NL-OMON38114
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Peritoneal carcinomatosis of colorectal origin diagnosed either by cytologic confirmation of malignant ascitis or by histologic or cytologic confirmation at laparotomy.
Exclusion Criteria
Age under 18 years
Previous chemotherapy, exept adjuvant cheomtherapy with an interval between adjuvant chemotheray and start of neo-adjuvant chemotherapy of al least 12 months.
History of other malignancy, except basal cell carcinoma
Advanced liver disease, Child Pugh score > 2
WHO performance status above 2
Unable to give written informed consent
Creatine clearance < 30 ml/min
Liver or extra-abdominal metastasis
Neurotoxicity > grade 2 according to CTC AE 3.0
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objectives<br /><br>Phase 1 and Phase 2:<br /><br>• To evaluate the efficacy of neoadjuvant chemotherapy with regard to the<br /><br>number of patients in whom a complete cytoreductive surgery can be performed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives<br /><br><br /><br>1)To evaluate the safety of neo-adjuvant chemotherapy and CRS with HIPEC in<br /><br>peritoneal carcinomatosis of colorectal origin<br /><br>2)The response of peritoneal carcinomatosis to chemotherapy according to RECIST<br /><br>criteria and postoperative pathological examination<br /><br>3) 30-day or in-hospital mortality following CRS+HIPEC after neo-adjuvant<br /><br>chemotherapy.<br /><br>4) Quality of life as measured by the EORTC-QLQ C30 quality of life<br /><br>questionnaire<br /><br>5) Morbidity of surgery according to the NCI-CTC v3.0<br /><br>6) The effect of chemotherapy and CRS with HIPEC on intestinal barrier function<br /><br>as measured by IFAB levels.<br /><br>7) The percentage of patients able to complete full treatment </p><br>