Liver Transplantation and Colorectal Cancer
Colorectal Cancer, Liver Metastasis
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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.
Additional inclusion criteria for patients included in part Arm D:
Patients with expected overall survival of 6-12 months without a liver transplant.
The patient might be included without further chemotherapy treatment. Patients may have resectable pulmonary lesions at time of inclusion in the present study.
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.
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
A: Transplantation or resection (randomized)
B: Liver transplantation
C:Liver transplantation
D:Liver transplantation
Liver transplantation or liver resection by 1:1 randomization (open label)
For non-resectable patients metachronous disease.
For non-resectable patients synchronous disease.
For non-resectable patients synchronous disease.