Liver Transplantation and Colorectal Cancer

Launched by OSLO UNIVERSITY HOSPITAL · Nov 23, 2011

Keywords

ClinConnect Summary

This clinical trial is investigating whether liver transplantation can help patients with colorectal cancer that has spread to the liver live longer and have a better quality of life compared to those who receive surgery to remove the tumors. Currently, liver transplantation is not commonly done for patients with this type of cancer due to previously low success rates. However, new research suggests that with better patient selection, the chances of surviving for five years after the transplant could be around 50%.

To participate in this trial, patients must have a specific type of colorectal cancer, show no signs of cancer spread beyond the liver, and meet certain health criteria. Eligible participants will receive either a liver transplant or surgery, depending on the study group they are assigned to. Throughout the trial, patients will be closely monitored to assess their health and any changes in their cancer. This study aims to refine the selection process for liver transplantation and potentially improve outcomes for patients with liver metastases from colorectal cancer.

Gender

ALL

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.