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Clinical Trials in Norway / NCT03494946
Recruiting Not applicable

Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

NCT03494946 · tracked via the Priya Life Science Norway tracker
Phase
Not applicable
Started
2016-12-05
Last updated
2024-02-06

Condition(s) studied

Liver MetastasesColorectal Cancer

Investigational drug(s) / intervention(s)

Liver transplantationChemotherapy

Chemotherapy: May include chemotherapy, TACE, SIRT or other available treatment options.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Oslo University Hospital Oslo Norway Recruiting

More Oslo University Hospital trials in Norway

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03494946 on ClinicalTrials.gov ↗ ← All trials in Norway