Fase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases
- Conditions
- irresectabel colorectal livermetastases, colorectale levermetastasen
- Registration Number
- NL-OMON28533
- Lead Sponsor
- eiden University Medical Centre
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
Liver metastases of histologically confirmed primary colorectal adenocarcinoma;
- Resection of primary tumor > 1 month before IHP;
Exclusion Criteria
Biological age <18 and >65 years
- WHO performance status ≥ 2 (Appendix A);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Response rate expressed by RECIST criteria, after two percutaneous liver perfusions with melphalan at a six week interval;<br /><br>•Number of curative resections after percutaneous perfusion.
- Secondary Outcome Measures
Name Time Method •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.