Hepatic arterial infusion PUMP chemotherapy combined with systemic therapy versus systemic therapy alone as Induction Therapy for initially unresectable colorectal liver metastases: a randomised controlled trial
Phase 3
Not yet recruiting
- Conditions
- 'Colorectal liver metastases' 'colon cancer with liver metastases'100179901001981510017991
- Registration Number
- NL-OMON56934
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 306
Inclusion Criteria
• Unresectable CRLM (as assessed by National Liver Panel)
• Resectable primary tumour without indication for neoadjuvant treatment
• No previous systemic therapy for colorectal cancer
• No extrahepatic metastases
• Suitable arterial anatomy for pump placement
• Written informed consent
Exclusion Criteria
• DPD-deficiency
• MMR-deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>overall survival (OS). </p><br>
- Secondary Outcome Measures
Name Time Method <p>progression-free survival (PFS), conversion-to-resection rate, R0/R1 resection<br /><br>rate, hepatic progression-free survival (hPFS), radiological response,<br /><br>pathological response, complication rates for pump placement, surgery for the<br /><br>primary tumour and conversion surgery, toxicity of HAIP and systemic therapy,<br /><br>quality of life and cost effectiveness.</p><br>