Patients with resectable colorectal liver metastases
Conditions
Interventions
Sponsors
Erasmus MC Kanker Instituut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years. • ECOG performance status 0 or 1 • Clinical Risk Score (CRS) of 0-2, and by discretion of the principal investigator • 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: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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. • Prior hepatic radiation or resection. • Two-staged liver resections • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first objective of this study is to evaluate the safety and feasibility of adjuvant HAIP chemotherapy after resection of CLM in 2 centres in the Netherlands.;Secondary Objective: The second objective is to determine whether CT angiography can replace a nuclear medicine scan to rule out extrahepatic perfusion of the pump.;Primary end point(s): The primary outcome for safety is the percentage of 90-day postoperative complications (Clavien-Dindo classification, grade III or higher). The primary outcome for feasibility is the percentage of successful administration of at least one cycle of HAIP chemotherapy.;Timepoint(s) of evaluation of this end point: 90 days after surgery of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome are treatment related adverse events grade III or higher (chemotherapy related CTCAE, grade III or higher; appendix D) until 4 weeks after the end of treatment and the accuracy of CT angiography to detect extrahepatic perfusion.;Timepoint(s) of evaluation of this end point: 4 weeks after end of treatment of the last included patient | — |
Countries
Netherlands
Contacts
Public ContactResearcher
Erasmus MC Kanker Instituut
Outcome results
None listed