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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2027
  • participants needed
    25
  • sponsor
    Oslo University Hospital
Updated on 28 October 2022
cancer
blood test
metastasis
liver metastasis
primary tumor
rectal carcinoma
adenocarcinoma
hepatectomy

Summary

Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.

The investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results.

The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection.

The investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.

Description

Arm D: use of extended criteria donors (ECD)

Details
Condition Colorectal Cancer, Liver Metastasis
Treatment Liver transplantation and liver resection
Clinical Study IdentifierNCT01479608
SponsorOslo University Hospital
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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