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โ† Trials
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Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

RecruitingNAAges 18 Years - anyAllOslo University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Liver transplantation
  • Chemotherapy
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Where

1 site
Oslo University Hospital
Oslo, Norway
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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