A Randomized Controlled Clinical Trial to Evaluate the Benefit and Efficacy of Liver Transplantation as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma
Inclusion Criteria:
- Histologically verified adenocarcinoma in colon or rectum.
- No signs of extra hepatic metastatic disease or local recurrence according to PET/CT
scan.
- No signs of extra hepatic metastatic disease or local recurrence according to CT or
MR (thorax/abdomen/pelvis) scan within 4 weeks prior to the faculty meeting at the
transplant unit
- No signs of local recurrence judged by colonoscopy / CT colography within 12 months
prior to the faculty meeting at the transplant unit
- Good performance status, ECOG 0 or 1.
- Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75,
Bilirubin<2 x upper normal level, ASAT,ALAT<5 x upper normal level, ,Creatinine <1.25
x upper normal level. Albumin above lower normal level.
- Standard surgical procedure with adequate resection margins including circumferential
resection margins (CRM) of at least ≥2mm for rectal cancer patients.
- Signed informed consent and expected cooperation of the patients for the treatment
and follow up must be obtained and documented according to GCP, and national/local
regulations.
- Received at least 3 cycles of chemotherapy (6 weeks of treatment), with no increase
in size of the lesions according to RECIST-criteria
Additional inclusion criteria for patients included in part A:
- Six or more liver metastases technically resectable
Additional inclusion criteria for patients included in part B:
- Metachronous liver metastases (more than 12 months from diagnosis of CRC and/or end
of adjuvant treatment)
- Pathological classification of primary tumor as pN0 disease.
- CEA<100 ng/ml at time of primary diagnosis as well as at time of diagnosis of
metastatic disease.
- Liver metastases not eligible for curative liver resection.
- Before start of 1. line chemotherapy, no lesion should be larger than 10 cm and total
number of lesions should be 20 or less.
- At least 10% response (RECIST-criteria) on 1. line chemotherapy. Patients must be
accepted for transplantation before progressive disease on 1. line chemotherapy.
Additional inclusion criteria for patients included in part C:
- Liver metastases not eligible for curative liver resection.
- Received 1.line treatment.
- Before start of 2. or 3. line chemotherapy, no lesion should be larger than 10 cm and
total number of lesions should be 20 or less.
- At least 10% response (RECIST-criteria) on 2. or 3. line chemotherapy. Patients must
be accepted for transplantation before progressive disease on 2. or 3. line
chemotherapy.
- Two years or more time span from the CRC diagnosis and date of being listed on the
transplantation list.
Exclusion Criteria:
- Weight loss >10% the last 6 months
- Patient BMI > 30
- Other malignancies
- Prior extra hepatic metastatic disease or local relapse.
- Patients who have not received standard pre-operative, per-operative or
post-operative treatment for the primary CRC.
- Palliative resection of primary CRC tumor.
- Previous randomization in this trial.
- Any reason why, in the opinion of the investigator, the patient should not
participate.