Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study
- Conditions
- Colorectal liver metastasesmetastases in the liver of colorectal cancer1001981510019818
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
• Age >= 18 years.
• ECOG performance status 0 or 1
• Clinical Risk Score (CRS) of 0-5
• Histologically confirmed colorectal cancer (CRC)
• Radiologically confirmed and resectable CLM
• Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT or MRI with adequate arterial phase.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 15 days prior to inclusion.
• 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.
• Prior hepatic radiation or resection.
• Two-staged liver resections
• (Partial) portal vein thrombosis
• Pregnant women or lactating women.
• History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
• Organ allografts requiring immunosuppressive therapy.
• Serious, non-healing wound, ulcer, or bone fracture.
• Chronic treatment with corticosteroids (dose of >= 10 mg/day methylprednisolone equivalent excluding inhaled steroids).
• Serious infections (uncontrolled or requiring treatment).
• Current or recent (within the 28 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome for safety is the percentage of 90-day postoperative<br /><br>complications (Clavien-Dindo classification, grade III or higher). The primary<br /><br>outcome for feasibility is the percentage of successful administration of at<br /><br>least one cycle of HAIP chemotherapy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome are treatment related adverse events grade III or higher<br /><br>(chemotherapy related CTCAE, grade III or higher; appendix D) until 4 weeks<br /><br>after the end of treatment and the accuracy of CT angiography to detect<br /><br>extrahepatic perfusion.</p><br>