Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases in patients with a low clinical risk score – a randomized controlled trial
- Conditions
- Adjuvant treatment, Hepatic Arterial Infusion Pump (HAIP) chemotherapy, Resectable colorectal liver metastases
- Registration Number
- NL-OMON26427
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 230
Inclusion Criteria
•Age ≥ 18 years.
•ECOG performance status 0 or 1 (Appendix C).
Exclusion Criteria
•Presence of extrahepatic disease (including positive portal lymph nodes) at the time of liver resection or any time since CRC diagnosis. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
•Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously without evidence of recurrence.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is progression free survival (PFS).
- Secondary Outcome Measures
Name Time Method Secondary endpoints include OS, PFS in the liver, postoperative complications, adverse events, quality of life, and cost effectiveness. Also, the accuracy of CT angiography to detect extrahepatic perfusion will be evaluated. Next, we aim to identify predictive biomarkers for the efficacy of HAIP chemotherapy. Furthermore, the pharmacokinetic profile of intra-arterial administration of floxuridine will be established.