Fase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases
- Conditions
- irresectable hepatic metastasesliver metastases100198151002747610019818
- Registration Number
- NL-OMON41379
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
- Liver metastases of histologically confirmed primary colorectal adenocarcinoma
- Resection of primary tumor > 1 month before IHP
- Irresectable metastases confined to the liver based on CT-Thorax/abdomen and PET imaging
- Metastases measurable on CT-scan
- Informed consent
- Life expectancy > 4 months
- Leukocytes * 3.0 X 10^9/L
- Thrombocytes * 100 X 10^9/L
- Creatinine clearance * 40 ml/min
- Bilirubin <17 µmol/L
- APTT < 32.5 sec
- PT < 13.7 sec
- Biological age <18 and >75 years
- WHO performance status * 2 (Appendix A)
- < 40% healthy liver tissue
- Aberrant vascular anatomy, which impedes IHP (e.g. aberrant right or left hepatic artery, severe atherosclerosis, vascular dissections)
- Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections, other liver disease)
- Incompetent / Mentally disabled
- Pregnancy, inadequate anticonception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints<br /><br>* Response rate expressed by RECIST criteria, after two percutaneous liver<br /><br>perfusions with melphalan and a six week interval<br /><br>* Number of curative resections after percutaneous perfusion</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br>* Safety of percutaneous liver perfusions with the Delcath 2nd generation system<br /><br>* Overall survival and overall progression free survival<br /><br>* Duration of response and duration of stable disease<br /><br>* Quality of life</p><br>