To evaluate if the addition of liver transplantation primarily utilizing liver grafts from extended criteria donors not utilized for approved indications to conventional treatment of non-resectable/ non-abatable colorectal liver metastases (CLM) increases overall survival compared to best alternative care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Patients will be treated with Ltx at Sahlgrenska University Hospital, Göteborg, or Karolinska University Hospital, Huddinge.
All available treatments as well as other experimental treatments are tolerated, however no cross-over to other arm will be allowed.
Transplant Institute, Sahlgrenska University Hospital
Gothenburg, Sweden
Transplantation Unit, Karolinska University Hospital
Stockholm, Sweden
Five-year overall survival
Percentage of subject who reach the endpoint of overall survival
Time frame: randomization to follow up at 5 years
Two-year overall survival
Percentage of subject who reach the endpoint of overall survival
Time frame: randomization to follow up at 2 years
Median overall survival
Defined as time to death
Time frame: : Date of randomization until the date of death from any cause, assessed up to 5 years
Progression-free survival
Defined as time from randomization to progress of existing lesions, or appearance of new lesions, within the liver according to RECIST criteria (version 1.1) using CT or MRI and analysed using Kaplan-Meier and the log-rank test.
Time frame: Date of randomization until the date of documented progression of existing lesions or appearance of new lesions, assessed up to 5 years
Hepatic progression-free survival
Defined as time from randomization to progress of existing lesions in the liver , or appearance of new lesions in the liver, according to RECIST criteria (version 1.1) using CT or MRI and analysed using Kaplan-Meier and the log-rank test.
Time frame: Date of randomization until the date of documented progression of existing lesions or appearance of new lesions in the liver, assessed up to 5 years
Extrahepatic recurrence-free survival
Defined as time from randomization to appearance of new extra-hepatic lesions, using CT or MRI and analysed using Kaplan-Meier and the log-rank test.
Time frame: Date of randomization until the date of documented appearance of new extra-hepatic lesions, assessed up to 5 years
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Changes in quality of Life assessed with Euroqol Group Questionaire 5D-3L (EQ-5D-3L)
Assessed with EQ-5D-3L
Time frame: baseline, 3, 6, 12, 18, 24, 36 and 60 months
Health economic evaluation
Estimation of Quality Adjusted Life Year (QALY) assessed with EQ-5D-3L
Time frame: baseline, 3, 6, 12, 18, 24, 36 and 60 months