LIver recurrence after hepatectomy for CRLM.
Conditions
Interventions
Trade Name: FUDR
Product Name: Floxuridine
Product Code: Floxuridine
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults with recurrent resectable CRLM without a history of EHD. • Age = 18 years. • ECOG performance status 0 or 1 (Appendix A). • Histologically confirmed colorectal cancer (CRC). • Liver only recurrence after previous resection of index CRLM • Radiologically confirmed and resectable CRLM. Criteria for resectability are outlined in section 5.1. • Positioning of a catheter for HAIP chemotherapy is technically feasible (see chapter 5) based on a CT with excellent arterial phase. The default site for the catheter insertion is the gastroduodenal artery (GDA). Accessory or aberrant hepatic arteries are no contraindication for catheter placement. The GDA should have at least one branch to the liver remnant; accessory or aberrant hepatic arteries should be ligated to allow for cross perfusion to the entire liver through intrahepatic shunts. • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 15 days prior to inclusion: o absolute neutrophil count (ANC) =1.5 x 109/L o platelets =100 x 109/L o HB = 5.5 mmol/L o Total bilirubin = 1.5 UNL o ASAT = 5 x UNL o ALAT = 5 x UNL o alkaline phosphatase = 5 x UNL o (calculated) glomerular filtration rate (GFR) >30 ml/min. • Written informed consent must be given according to ICH/GCP, and national/local regulations. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • A positive history of extrahepatic disease (including positive portal lymph nodes) at any time since CRC diagnosis. Patients with small (= 1 cm) extrahepatic lesions that are too small to characterize 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.. • CRLM requiring two-staged liver resections • recurrent CRLM at same location as previously resected/ablated CRLM and <6 months after its resection. • Known DPYD-deficiency. • Pregnant 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). • Inclusion in another interventional clinical study with survival as primary outcome. • 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: Primary Objective: The first objective of this study is to evaluate efficacy of adjuvant HAIP chemotherapy after repeat hepatectomy for recurrent CRLM in the Erasmus MC. Secondary Objective(s): The second objective is to determine treatment related adverse events (grade III and higher). ;Secondary Objective: Secondary Objective(s): The second objective is to determine treatment related adverse events (grade III and higher), progression free survival and overall survival. ;Primary end point(s): Primary Objective: The first objective of this study is to evaluate efficacy of adjuvant HAIP chemotherapy after repeat hepatectomy for recurrent CRLM in the Erasmus MC. ;Timepoint(s) of evaluation of this end point: 1 year after inclusion of last patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Objective(s): The second objective is to determine treatment related adverse events (grade III and higher). ;Timepoint(s) of evaluation of this end point: Multiple timepoints after inclusion of last patiënt, | — |
Countries
Netherlands
Contacts
Public Contactdoctor/ PhD cantdidate
Erasmus MC
Outcome results
None listed