None listed
Conditions
Interventions
Drug : Additional oxaliplatin chemotherapy through the hepatic artery is planned along with injection chemotherapy (FOLFIRI therapy given intravenously+-target therapy) that is used as the first line
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed colorectal cancer (CRC), and radiologic or histologic proof of liver metastasis. 2. Unresectability of the CRLM will be confirmed by a centralized multidisciplinary expert panel (composed of surgeons, radiologists, interventional radiologists and medical oncologists). The panel will review the CT scan and MRI of the patients (weekly web conference). Non-resectability criteria (one of the following criteria): - Upfront R0/R1 resection of all CRLM (that leaves at least two adequately perfused and drained segments) is not possible - Liver metastases in contact with major vessels of the remnant liver which would require resection of the vessel for an R0 resection (i.e., tumor involvement of main portal right and left portal veins, of the three main hepatic veins, or of the retrohepatic vena cava) 3. At least one measurable liver metastasis according to the RECIST v1.1 4. Age =18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 6. Life expectancy of at least 3 months 7. Normal liver function International normalized ratio (INR) 1500/mm³ 9. Platelet >100 x 109/L (transfusion allowed) 10. Hemoglobin >9 g/dL (transfusion allowed) 11. Bilirubin 30 mL/min (Cockcroft and Gault formula) 14. Urine dipstick for proteinuria of less than 1+ is required within 7 days prior to study entry; if urine dipstick is >= 2+ then a 24 hour urine for protein must demonstrate =< 1 gm of protein in 24 hours to allow participation in the study; NOTE: Urinalysis is also acceptable 15. Informed consent signed by the patient or his/her legal representative
Exclusion criteria
Exclusion criteria: 1. Patient eligible for curative-intent treatment of CRLM (i.e. resection and/or thermoablation), according to the local multidisciplinary team and/or the central review. Definitive anatomical contraindication to complete surgical resection (any of the following criteria): - More than two lesions in all liver segments - Bilobar liver metastasis and more than three lesions >3 cm in the hepatic lobe the least affected (i.e. the future remnant liver) - Bilobar liver metastasis and disease liver extend >50% 2. Extrahepatic tumor disease (except =3 lung nodules 50 years old or 2) Age = 50 years old and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range (>40 mIU/mL), 3) prior bilateral oophorectomy 17. Patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| curative-intent resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;safety profile | — |
Countries
Korea, Republic of
Contacts
Public ContactHan Sang Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed