RecruitingNot ApplicableNCT03494946

Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy

Sponsor

Oslo University Hospital

Enrollment

30 participants

Start Date

Dec 5, 2016

Study Type

INTERVENTIONAL

Conditions

Liver Metastases

Summary

The trial is a randomized control trial. Patients are randomized between Ltx and other treatment that may include further chemotherapy, TACE, SIRT or other available treatment options. The patients will be randomized 1:1 to Ltx and chemotherapy/other treatment options.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Histologically verified adenocarcinoma in colon/rectum.
Liver metastases, not amenable to liver resection
No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all \< 15mm.
No signs of extra hepatic metastatic disease on CT or MRI thorax/abdomen/pelvis within 6 weeks prior to the faculty meeting at the transplant unit, except resectable lung lesions all \< 15mm.
No signs of extra hepatic metastatic disease on PET/CT within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all \< 15mm
Good performance status, ECOG 0 or 1.
Satisfactory blood tests Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<1.5 x upper normal level, ASAT, ALAT\<5 x upper normal level, Creatinine \<1.25 x upper normal level. Albumin above lower normal level.
Signed informed consent and expected cooperation of the patients for the treatment and followup must be obtained and documented according to GCP, and national/local regulations.
All patients should have progressive disease according to RECIST-criteria, or intolerance to 1. line chemotherapy. Patients must be randomized before evaluation 8-12 weeks after starting 2. line chemotherapy.

Exclusion Criteria10

Weight loss \>10% the last 6 months
Patient BMI \> 30
Previous resection of local relapse or non-hepatic metastasis within the last 2 years or resection of pulmonary or liver hilus lymph node metastases the last year.
Previous diagnosed bone or CNS metastatic disease or thoracic or abdominal metastatic lymph nodes.
Previous diagnosed cancer mammae or malignant melanoma.
Non resected or palliative resection of primary CRC tumor.
Liver metastases affecting the diaphragm determined by CT-scan and/or ultrasound examination.
Liver lesion\>10cm
Three negative prognostic factors at time of randomization (CEA\>80, less than 2 years from diagnosis, diameter of largest liver lesion \>5.5cm).
Any reason why, in the opinion of the investigator, the patient should not participate.